Identity
- Trade Name
- HYPERFLEX EUDAMEDFDA UDI
- Generic Name
- Orthopaedic guidewire, single-use FDA UDIOrthopaedic guidewire, reusable FDA UDI
- Device Name
- Orthopedic, Non-active, Reusable Surgical Instrument, Drilling EUDAMEDOrthopedic, Non-active, Instrument, Guide Wire EUDAMEDHYPERFLEX GUIDEWIRE NITINOL 18.5 IN STERILE, 1.6 X 470 MM (.062 X 18.5 IN.) FDA UDIHYPERFLEX NITINOL GUIDE WIRE, 1.6 X 229 MM (.062" X 9") FDA UDIHYPERFLEX FLEXIBLE GUIDE WIRE, 1.6 X 356 MM (.062" X 14") FDA UDI
- Model / Reference
- 8571 EUDAMEDFDA UDI8572 EUDAMEDFDA UDI8573D EUDAMEDFDA UDI
- Description
- HYPERFLEX GUIDEWIRE NITINOL 18.5 IN STERILE, 1.6 X 470 MM (.062 X 18.5 IN.) FDA UDIHYPERFLEX NITINOL GUIDE WIRE, 1.6 X 229 MM (.062" X 9") FDA UDIHYPERFLEX FLEXIBLE GUIDE WIRE, 1.6 X 356 MM (.062" X 14") FDA UDI
Identifiers
- Catalog Number
- 8573D FDA UDI8571 FDA UDI8572 FDA UDI
- Primary DI / UDI-DI
- 10845854025314 EUDAMEDFDA UDI10845854025338 EUDAMEDFDA UDI10845854041635 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585408434D9 EUDAMEDB-10845854041635 EUDAMED
- Direct Marketing DI
- 20845854025311 EUDAMED20845854025335 EUDAMED
- 510(k) Number
- K941711 FDA UDI
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMEDK030202 ARTHROSCOPY GUIDE WIRES, SINGLE-USE EUDAMED
- GMDN Term
- Orthopaedic guidewire, single-use FDA UDIOrthopaedic guidewire, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMED
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMEDEUDAMED
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 UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 18.5 Inch FDA UDI
Hyperflex by Conmed Corporation — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 084585408434D9 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 084585408434D9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (8)
- EUDAMED 550ca8e2-e60b-48a1-91bf-cd509ad38e24 61 fields · synced Jul 14, 2026
- EUDAMED 253631d9-a547-4238-8ca3-5d810bb28a67 61 fields · synced May 18, 2026
- EUDAMED 439235a3-6fbb-4372-a6e5-204b15ce9210 61 fields · synced May 19, 2026
- FDA UDI 051b867e-573b-47e9-a20a-0fe5a8214568 37 fields · synced May 30, 2026
- FDA UDI 460c1f99-475a-4163-9777-1b92b74431e8 36 fields · synced May 30, 2026
- FDA UDI cd9b1e2a-51cf-4fa3-9b95-e5c16bd8c3bb 36 fields · synced May 30, 2026
- EUDAMED a7981b7f-a7fd-479b-891d-e0387cf1abab 61 fields · synced Jul 9, 2026
- EUDAMED db56a945-3d41-43ec-bd78-187e6ae888ec 61 fields · synced Jul 14, 2026