ENDO REACH REC Reloads
by Reach Surgical, Inc. 12 variants
Ref REC60WHTModel REC45GRA, REC45WHT, REC45BLU, REC45GLD, REC60GRA, REC60WHT, REC60BLU, REC60GLD, IMST60TAN, IMST60PUL, IMST45TAN, IMST45PUL.
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69538158P634D 06953815843321 | Date23 Dec 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Single Use Loading Units for Endoscopic Linear Cutting Staplers
- Model / Reference
- REC45GRA, REC45WHT, REC45BLU, REC45GLD, REC60GRA, REC60WHT, REC60BLU, REC60GLD, IMST60TAN, IMST60PUL, IMST45TAN, IMST45PUL.
- Primary DI / UDI-DI
- 06953815843321
- Basic UDI-DI
- 69538158P634D
- EMDN Code
- H02030106 Linear stapler cartridges for videosurgery
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011148
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Reach Surgical, Inc.
Properties
Other properties (11)
- Reusable: 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