Identity
- Trade Name
- BONDEK FDA UDI
- Generic Name
- Polyglycolic acid suture FDA UDI
- Device Name
- Bondek Plus Violet Braided Polyglycolic Acid Size 0 48" FX45 Needle C-2 Needle Bard FDA UDI
- Model / Reference
- IPN000886 FDA UDI
- Description
- Bondek Plus Violet Braided Polyglycolic Acid Size 0 48" FX45 Needle C-2 Needle Bard FDA UDI
Identifiers
- Catalog Number
- BON100 FDA UDI
- Primary DI / UDI-DI
- 04026704604661 FDA UDI
- FDA Product Code
- GAM FDA UDI
- GMDN Term
- Polyglycolic acid suture FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4493 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polyglycolic acid suture
Bondek by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MEGASORB — MERIL ENDO SURGERY PRIVATE LIMITED · Class II
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- WEGO-PGA Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI a6a97716-7eb3-4e6f-b24a-cd17eb30ad34 37 fields · synced May 31, 2026