Hollister
by Hollister Incorporated United States EUDAMEDGUDID
Ref 7724
Product code EXBEMDN A100302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number610075D01P060S01828K | Date15 Apr 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10610075103420 | Date1 Dec 2022 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Colostomy irrigation kit, single-use
- Device Name
- Stoma Irrigator Drain
- Model / Ref / Catalog
- 7724
- Primary DI / UDI-DI
- 10610075103420 EUDAMED15390166082661 EUDAMED00610075077243 GUDID
- Basic UDI-DI
- 610075D01P060S01828K
- Unit of Use DI
- 00610075083404, 35390166082665
- FDA Product Code
- EXB
- EMDN Code
- A100302 Abdominal ostomy drainage / irrigation bags
- GMDN Term
- Colostomy irrigation kit, single-use
- Device Class
- Class I
- Regulation Number
- 876.5900
- Market of Registration
- Ireland
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
- Size
- Lumen/Inner Diameter — 76 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | 10610075103420 15390166082661 | 00610075077243 |
Manufacturer details
- EUDAMED SRN
- US-MF-000027818
- Authorised representative
- Hollister ULC IE-AR-000022119
Other devices from Hollister Incorporated
Properties & raw data
Show properties, registry sources and raw records
Other properties (20)
- 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
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Manufacturing Date: No
Sources (3)
- EUDAMED 013aef2d-a6a7-41bb-b7f2-ad56ce4b84a0
- FDA UDI 3a6aaa92-742c-443a-8e04-60457981490b
- EUDAMED 15390166082661|610075D01P060S01828K