Identity
- Trade Name
- CONCEPT, TRAM FDA UDI
- Generic Name
- Suturing unit, reusable FDA UDI
- Device Name
- CONCEPT SUTURE TRAM RETROGRADE SUTURE RETRIEVER, STRAIGHT FDA UDI
- Model / Reference
- C6800 FDA UDI
- Description
- CONCEPT SUTURE TRAM RETROGRADE SUTURE RETRIEVER, STRAIGHT FDA UDI
Identifiers
- Catalog Number
- C6800 FDA UDI
- Primary DI / UDI-DI
- 10845854031193 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Suturing unit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Suturing unit, reusable
Concept, Tram by Conmed Corporation — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Suturing unit, reusable.
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- HAT-TRICK — Smith & Nephew, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (2)
- FDA UDI 029e83ad-a2b5-4812-9a87-fff84d03da9b 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026