Penfield Elevator THE154575
by Joimax, Inc.
Ref THE154575
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 | Number42503371PALPENDG5 04250337120490 | Date29 Apr 2024 | StatusActive |
| United States | GUDID listing GUDID | Number04250337120490 | Date29 Sep 2023 | 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- Withdrawn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
- Penfield Elevator blunt EUDAMEDPenfield Elevator GUDID
- Generic Name
- Bone lever/elevator, reusable
- Device Name
- Endo-Flexprobe
- Model / Ref / Catalog
- THE154575
- Primary DI / UDI-DI
- 04250337120490
- Basic UDI-DI
- 42503371PALPENDG5
- Direct Marketing DI
- 04250337120490
- FDA Product Code
- GFI
- EMDN Code
- L110599 Neurosurgery spreaders and retractors, reusable - other
- GMDN Term
- Bone lever/elevator, reusable
- Device Class
- Class I
- Regulation Number
- 878.4800
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Microwave Radiation
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Contains Latex | No | Yes |
Other devices from Joimax, Inc.
Properties
Other properties (18)
- Sterile: No
- Single Use: No
- Implantable: 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
- Serial Number: No
- Expiration Date: No