Instrument Hi-Uhrk-26
Ref HI-UHRK-26Model 08858250000793SP
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number08858250000793SP | Date19 Jun 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07613327228229 | Date24 Sep 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Instrument
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device Name
- TF-018 Class I (r) - Separating
- Model / Ref / Catalog
- HI-UHRK-26, 08858250000793SP
- Primary DI / UDI-DI
- 07613327228229
- Basic UDI-DI
- 08858250000793SP
- Direct Marketing DI
- 07613327228229
- FDA Product Code
- LPH, LZO, HWC, MBL, MAY, LWJ, MEH, KWY, KWL, JDI, KWZ
- EMDN Code
- L091106 Instruments for the preparation of tissue implants in orthopaedic and traumatological surgery, reusable
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 888.3358, 888.3353, 888.3040, 888.3360, 888.3390, 888.3350, 888.3310
- Market of Registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Other devices from Howmedica Osteonics Corp.
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No