Identity
- Trade Name
- SUTURE INSTRUMENT FDA UDI
- Generic Name
- Suturing unit, reusable FDA UDI
- Device Name
- SUTURE INSTRUMENT FOR SUBCUTANEOUS FASCIAL CLOSURE,Ø2.3 MM WORKING LENGTH 140 MM FDA UDI
- Model / Reference
- S.0904.07 FDA UDI
- Description
- SUTURE INSTRUMENT FOR SUBCUTANEOUS FASCIAL CLOSURE,Ø2.3 MM WORKING LENGTH 140 MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049047087892 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Suturing unit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Suturing unit, reusable
Suture Instrument by Gimmi GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Suturing unit, reusable.
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- Arthrex® — Arthrex, Inc. · Class I
- HAT-TRICK — Smith & Nephew, Inc. · Class I
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
- Gimmi GmbH
Sources (1)
- FDA UDI dead26db-9723-47de-89c3-182749c0e5ea 34 fields · synced Jun 8, 2026