Kolibri RCM012
Kolibri RCM012 is a device classified as Unclassified made by Coloplast A/S, listed in FDA GUDID since 20 Jan 2023 (UDI-DI 05701780271356), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05701780271356 | Date20 Jan 2023 | StatusListed |
Official records
- AccessGUDID record 05701780271356
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Kolibri
- Generic name
- Nephrostomy catheter
- Model / Ref / Catalog
- RCM012
- Primary DI / UDI-DI
- 05701780271356
- FDA product code
- LJE
- GMDN term
- Nephrostomy catheter
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Size
- Catheter Gauge — 12 French
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