Identity
- Trade Name
- Ds12 4-0 Pl Gut 10"/25cm FDA UDI
- Generic Name
- Catgut suture, plain FDA UDI
- Device Name
- Ds12 4-0 Pl Gut 10"/25cm FDA UDI
- Model / Reference
- B531NS FDA UDI
- Description
- Ds12 4-0 Pl Gut 10"/25cm FDA UDI
Identifiers
- Catalog Number
- B531S FDA UDI
- Primary DI / UDI-DI
- 00848782012084 FDA UDI
- FDA Product Code
- GAL FDA UDI
- GMDN Term
- Catgut suture, plain 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
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
Category: Catgut suture, plain
A comprehensive medical device for suturing and wound closure, specifically designed for general soft tissue repair.
Similar devices
Also classified as Catgut suture, plain.
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- DemeGUT — DemeTECH Corp · Class II
- DemeGUT — DemeTECH Corp · Class II
- Premium UNIFY Plain Gut Sutures — APPLIED DENTAL, 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
- Surgical Specialties México, S. de R.L. de C.V.
Sources (1)
- FDA UDI 47194bee-9f34-45ba-886b-e526b011ba91 36 fields · synced Jul 12, 2026