Identity
- Trade Name
- Chromic Gut FDA UDI
- Generic Name
- Catgut suture, chromic FDA UDI
- Device Name
- Suture FDA UDI
- Model / Reference
- 1637CG FDA UDI
- Description
- Suture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840277406538 FDA UDI
- 510(k) Number
- K001299 FDA UDI
- FDA Product Code
- GAL FDA UDI
- GMDN Term
- Catgut suture, chromic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4830 FDA UDI
- Commercial Distribution
- 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
Category: Catgut suture, chromic
Chromic Gut by Riverpoint Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Catgut suture, chromic.
- DemeGUT — DemeTECH Corp · Class II
- DemeGUT — DemeTECH Corp · Class II
- ETHICON — Ethicon Inc. · Class II
- DemeGUT — DemeTECH Corp · Class II
- ETHICON — Ethicon Inc. · Class II
- ACE Surgical Ch Gut 3-0 30" Hr26 — Surgical Specialties México, S. de R.L. de C.V. · Class II
- DemeGUT — DemeTECH Corp · Class II
- DemeGUT — DemeTECH Corp · Class II
Cleared under the same submission
K001299 also covers:
- Chromic Gut — RIVERPOINT MEDICAL LLC
- Chromic Gut — RIVERPOINT MEDICAL LLC
- Chromic Gut — RIVERPOINT MEDICAL LLC
- Chromic Gut — RIVERPOINT MEDICAL LLC
- Chromic Gut — RIVERPOINT MEDICAL LLC
- Chromic Gut — RIVERPOINT MEDICAL LLC
- Chromic Gut — RIVERPOINT MEDICAL LLC
- Chromic Gut — RIVERPOINT MEDICAL LLC
- Chromic Gut — RIVERPOINT MEDICAL LLC
- Chromic Gut — RIVERPOINT MEDICAL LLC
- Chromic Gut — RIVERPOINT MEDICAL LLC
- Chromic Gut — RIVERPOINT MEDICAL LLC
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
- Riverpoint Medical Llc
Sources (1)
- FDA UDI 38038aff-1933-4cce-a307-cbc0c9236f86 34 fields · synced May 30, 2026