Arthrex® AR-8170-50C
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 |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number00888867043008 | Date14 Jun 2018 | StatusListed |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Arthrex®
- Generic Name
- Hand-held surgical retractor, reusableTendon/ligament bone anchor, non-bioabsorbableOrthopaedic fixation suture buttonImplantable bone washerLigament reconstruction instrument set, reusableOrthopaedic fixation plate, non-bioabsorbableOrthopaedic bone screw (non-sliding)
- Model / Ref / Catalog
- AR-8170-50C, AR-1588TB-1, AR-1288BTB-90, AR-1288-90, AR-1588CLS, AR-8959TDS, AR-2258-03, AR-8926SS, AR-1588TB-2, AR-8921CDS, AR-1588SBR-RT, AR-1588TN-3, AR-1588TB-5, AR-1588RT-13, AR-1588TB, AR-1588BTB-J, AR-8959-01S, AR-1588TB-3, AR-1588RT, AR-1588BTB2-IBSF, AR-1588TB-4, AR-8917DS, AR-8911DS, AR-1588SBR-RTT-IB, AR-1588TB-17, AR-1588R-IB, AR-8925T, AR-2370, AR-1588PF, AR-1288-75, AR-1288-70, AR-8926T, AR-2257-01, AR-8924SS, AR-1288BTB-110, AR-1588TN-1, AR-8907DS, AR-8958TDS, AR-9924-24, AR-2658BLO, AR-2257, AR-1588RT-07, AR-2658TR, AR-8919-SS, AR-1588TN-21, AR-1588SBR-RT-IB, AR-1588SBR-RTT, AR-1588TNT2, AR-1588TN-2, AR-1588RT-IB, AR-1589RT
- Primary DI / UDI-DI
- 00888867043008, 00888867019638, 00888867245761, 00888867245655, 00888867499119, 00888867352278, 00888867026452, 00888867049079, 00888867019645, 00888867049048, 00888867465220, 00888867284159, 00888867240582, 00888867019584, 00888867019621, 00888867095366, 00888867352254, 00888867157729, 00888867019553, 00888867428508, 00888867157736, 00888867048959, 00888867048805, 00888867501324, 00888867455795, 00888867363656, 00888867281608, 00888867224247, 00888867499065, 00888867245624, 00888867245617, 00888867049086, 00888867026407, 00888867265592, 00888867245808, 00888867019713, 00888867373990, 00888867249790, 00888867401082, 00888867340176, 00888867026391, 00888867019560, 00888867271814, 00888867377882, 00888867371903, 00888867465237, 00888867501317, 00888867426696, 00888867157767, 00888867291638, 00888867019812
- FDA Product Code
- MDM, MBI, HTN, GAT, HWC, HRS
- GMDN Term
- Hand-held surgical retractor, reusableTendon/ligament bone anchor, non-bioabsorbableOrthopaedic fixation suture buttonImplantable bone washerLigament reconstruction instrument set, reusableOrthopaedic fixation plate, non-bioabsorbableOrthopaedic bone screw (non-sliding)
- Device Class
- Class IClass II
- Regulation Number
- 878.4800, 888.3040, 888.3030, 878.5000
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- MRI Safety
- MR ConditionalMR Safe
Other devices from Arthrex, Inc.
Properties
Other properties (5)
- Contains Latex: No
- Over-the-Counter: No
- Combination Product: No
- HCT/P: No
- Serial Number: No