PINION PGA-PCL Knotless Suture (UDI PNCS101029BD)
Manufactured by MERIL ENDO SURGERY PRIVATE LIMITED
Device Regulatory Overview
The PINION PGA-PCL Knotless Suture (Model/Catalog Number: PNCS101029BD) is a medical device manufactured by MERIL ENDO SURGERY PRIVATE LIMITED. This product is indexed under FDA Product Code / Category Classification GAM within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- PNCS101029BD
- Product Code / EMDN
- GAM
- Device Name
- "The PINION PGA-PCL Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION PGA-PCL Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of poly (glycolide-co-caprolactone). PINION PGA-PCL Knotless Suture is provided undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.25 % by weight of the suture in sizes USP (EP) 4-0 (1.5), 3-0 (2), 2-0 (3) 0 (3.5), 1 (4) & 2(5). It is supplied with the attached stainless steel surgical needles. The polymer has been found to be nonantigenic, nonpyrogenic and eliciting only a slight tissue reaction during absorption. The PINION PGA-PCL Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots. The USP designations for diameter are applicable to the PINION PGA-PCL Knotless Suture material prior to barbing. After the creation of barbs, the PINION PGA-PCL Knotless Suture is identified as one size smaller than the non-barbed suture. This modification reduces the tensile strength of the suture similar to effect of knot tying in non-barbed suture. Therefore, the straight pull tensile strength of the PINION PGA-PCL Knotless Suture is comparable to the USP knot pull tensile strength for a non barbed suture of the equivalent size."
- Database Sync Date
- 2026-08-09 09:29:39
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of PINION PGA-PCL Knotless Suture?
The registered manufacturer of record for PINION PGA-PCL Knotless Suture is MERIL ENDO SURGERY PRIVATE LIMITED.
What is the Primary UDI-DI identifier for PINION PGA-PCL Knotless Suture?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is PNCS101029BD.
What classification code is assigned to this device?
This device is registered under product classification code GAM.
Similar Classification Devices (GAM)
Other Devices by MERIL ENDO SURGERY PRIVATE LIMITED
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