Identity
- Trade Name
- UNIFY Chromic Gut Surgical Sutures FDA UDI
- Generic Name
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
- Device Name
- Chromic Gut, XL 2-0, 36mm 1/2 Cir Taper point, 27" FDA UDI
- Model / Reference
- XL-C227T36 FDA UDI
- Description
- Chromic Gut, XL 2-0, 36mm 1/2 Cir Taper point, 27" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814639021318 FDA UDI
- FDA Product Code
- GAR FDA UDI
- GMDN Term
- Nylon suture, non-bioabsorbable, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5020 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
UNIFY Chromic Gut Surgical Sutures by Applied Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Applied Dental, Inc.
Sources (1)
- FDA UDI 32eada71-093a-4d0d-aad6-34a74cd01a8d 35 fields · synced May 30, 2026