Identity
- Trade Name
- REFLEX EUDAMEDFDA UDI
- Generic Name
- Skin stapler/staple, non-bioabsorbable FDA UDI
- Device Name
- Non-orthopedic, Non-active, Instrument, Stapler/Staple EUDAMEDReflex TL, Skin Stapler with tissue lift, 35 wide FDA UDI
- Model / Reference
- 3013 EUDAMEDFDA UDI
- Description
- Reflex TL, Skin Stapler with tissue lift, 35 wide FDA UDI
Identifiers
- Catalog Number
- 3013 FDA UDI
- Primary DI / UDI-DI
- 20653405050602 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20653405050602 EUDAMED
- FDA Product Code
- FZQ FDA UDIQQS FDA UDI
- EMDN Code
- H02010102 SKIN STAPLERS, SINGLE PATIENT EUDAMED
- GMDN Term
- Skin stapler/staple, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4320 FDA UDI878.4740 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Reflex by Conmed Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20653405050602 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 6141f8f9-cb04-4216-b375-9f4e44831cd1 61 fields · synced Jun 8, 2026
- FDA UDI 7ac998d8-03d8-4f44-babc-f891eb2e4795 36 fields · synced May 30, 2026