Identity
- Trade Name
- Chromic Gut FDA UDI
- Generic Name
- Catgut suture, chromic FDA UDI
- Device Name
- Absorbable Suture, P-13, 1x Strand FDA UDI
- Model / Reference
- SG5687GMDL FDA UDI
- Description
- Absorbable Suture, P-13, 1x Strand FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521212442 FDA UDI
- 510(k) Number
- K885018 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
- 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 18 Inch FDA UDI
Chromic Gut by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K885018 also covers:
- Chromic Gut — Covidien LP
- Chromic Gut — Covidien LP
- Chromic Gut — Covidien LP
- Chromic Gut — Covidien LP
- Chromic Gut — Covidien LP
- Chromic Gut — Covidien LP
- Chromic Gut — Covidien LP
- Chromic Gut — Covidien LP
- Chromic Gut — Covidien LP
- Chromic Gut — Covidien LP
- Chromic Gut — Covidien LP
- Chromic Gut — Covidien LP
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
- Covidien LP
Sources (1)
- FDA UDI ac4f751f-617a-4118-88f6-4a100932fb26 37 fields · synced May 31, 2026