Identity
- Trade Name
- ENDURE INDUSTRIES FDA UDI
- Generic Name
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
- Device Name
- Endure Sutures PGCL Undyed, 19mm, 3/8 CUTTING, 90cm, 3-0 FDA UDI
- Model / Reference
- E11F90CY19 FDA UDI
- Description
- Endure Sutures PGCL Undyed, 19mm, 3/8 CUTTING, 90cm, 3-0 FDA UDI
Identifiers
- Catalog Number
- E11F90CY19 FDA UDI
- Primary DI / UDI-DI
- 00840118614733 FDA UDI
- 510(k) Number
- K130737 FDA UDI
- FDA Product Code
- GAM FDA UDI
- GMDN Term
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Endure Industries by Endure Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130737 also covers:
- Bioviva-3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
- Premium UNIFY PGCL Surgical Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PGCL Surgical Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PGCL Surgical Sutures — APPLIED DENTAL, INC.
- UNIFY PGCL Surgical Sutures — APPLIED DENTAL, INC.
- UNIFY PGCL Surgical Sutures — APPLIED DENTAL, INC.
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Endure Industries, Inc.
Sources (1)
- FDA UDI 812176e2-8436-4208-b351-e459cc01e14a 37 fields · synced May 31, 2026