gudid
Primary ID: ICSI Injection Pipette
ASTEC (UDI ICSI Injection Pipette)
Manufactured by ASTEC BIO USA INC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ASTEC - Primary ID ICSI Injection Pipette
Device Regulatory Overview
The ASTEC (Model/Catalog Number: ICSI Injection Pipette) is a medical device manufactured by ASTEC BIO USA INC. This product is indexed under FDA Product Code / Category Classification PUC within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ICSI Injection Pipette
- Product Code / EMDN
- PUC
- Device Name
- 5.5-6m OD, 4.0m ID, 20-25 Tip Bevel, 20 Neck Angle, 1mm Tip to Elbow, Smooth Jaw, Spiked
- Database Sync Date
- 2026-08-09 09:06:20
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 ASTEC?
The registered manufacturer of record for ASTEC is ASTEC BIO USA INC.
What is the Primary UDI-DI identifier for ASTEC?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ICSI Injection Pipette.
What classification code is assigned to this device?
This device is registered under product classification code PUC.
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