← Back to catalogue
Retractor 4 Prong Sharp
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2586-14-000
by Tecomet, Inc
Identity
- Trade Name
- RETRACTOR 4 PRONG SHARP EUDAMEDTecomet FDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- Manipulative Instruments EUDAMEDRETRACTOR 4 PRONG SHARP FDA UDI
- Model / Reference
- 2586-14-000 EUDAMEDFDA UDI
- Description
- RETRACTOR 4 PRONG SHARP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841435121492 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841435145918V8 EUDAMED
- Direct Marketing DI
- 00841435121492 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
- GMDN Term
- Hand-held surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Retractor 4 Prong Sharp by Tecomet, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0841435145918V8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tecomet, Inc
- EUDAMED SRN
- US-MF-000027544
- Authorised Representative
- Meditec Source GmbH & Co. KG DE-AR-000009318
Sources (2)
- EUDAMED f183901b-12da-409b-bf91-e52a977dcf3a 61 fields · synced Sep 18, 2026
- FDA UDI 8da323fe-bee2-4f43-9e66-3d055bbc58d1 33 fields · synced May 30, 2026