gudid
Primary ID: PTSH-039-025-001-P2
Osteomesh (UDI PTSH-039-025-001-P2)
Manufactured by OSTEOPORE INTERNATIONAL PTE. LTD.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Osteomesh - Primary ID PTSH-039-025-001-P2
Device Regulatory Overview
The Osteomesh (Model/Catalog Number: PTSH-039-025-001-P2) is a medical device manufactured by OSTEOPORE INTERNATIONAL PTE. LTD.. This product is indexed under FDA Product Code / Category Classification GXP within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- PTSH-039-025-001-P2
- Product Code / EMDN
- GXP
- Device Name
- Dimensions: 39 x 25 x 1.25 mmMaterial: PCLIntended Use: The Osteopore PCL Scaffold Bone Filler is intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletalsystem.
- Database Sync Date
- 2026-08-09 09:15:12
Full Regulatory Attributes
🔒 Token Gated
{
"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 Osteomesh?
The registered manufacturer of record for Osteomesh is OSTEOPORE INTERNATIONAL PTE. LTD..
What is the Primary UDI-DI identifier for Osteomesh?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is PTSH-039-025-001-P2.
What classification code is assigned to this device?
This device is registered under product classification code GXP.
Similar Classification Devices (GXP)
Other Devices by OSTEOPORE INTERNATIONAL PTE. LTD.
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