Leg restraint two parts
by Baxter Medical Systems GmbH + Co. KG EUDAMEDGUDID
Active
Ref 1218829
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0887761GMN000015TZ | Date18 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00887761971936 | Date15 Dec 2022 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 24 Oct 2026.
Specification
- Trade Name
- Leg restraint two parts EUDAMEDPatient Support & Fixation GUDID
- Generic Name
- Patient positioning vacuum pad
- Model / Reference
- 1218829
- Primary DI / UDI-DI
- 00887761971936
- Basic UDI-DI
- 0887761GMN000015TZ
- FDA Product Code
- GDC, KXJ, JEA
- EMDN Code
- Z12011280 Patient positioning instruments - hardware accessories
- GMDN Term
- Patient positioning vacuum pad
- Device Class
- Class I
- Regulation Number
- 878.4960, 892.1980
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- DE-MF-000005071
Other devices from Baxter Medical Systems GmbH + Co. KG
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No