Global Apg+
by DePuy Ireland UC Ireland EUDAMEDGUDID
Ref 2236-00-010Model Bone-Resection Orthopaedic Reamer, Single-Use
Product code HTOEMDN P091301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0603295a005348Y | Date24 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10603295105770 | Date24 Sep 2018 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Bone-resection orthopaedic reamer, single-use
- Device Name
- Bone-Resection Orthopaedic Reamer, Single-Use
- Model / Ref / Catalog
- Bone-Resection Orthopaedic Reamer, Single-Use, 2236-00-010, 223600010
- Primary DI / UDI-DI
- 10603295105770
- Basic UDI-DI
- 0603295a005348Y
- Direct Marketing DI
- 10603295105770
- FDA Product Code
- HTO
- EMDN Code
- P091301 Orthopaedic implant reamers, single-use
- GMDN Term
- Bone-resection orthopaedic reamer, single-use
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 888.4540
- Market of Registration
- Ireland
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- IE-MF-000007377
Other devices from DePuy Ireland UC
Properties & raw data
Show properties, registry sources and raw records
Other properties (20)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED c4eb85f5-9a25-443c-8d9c-a1adf90647da
- FDA UDI 8044b2b1-7015-4e6b-85cd-f51aa3b50af3