Disposable Emr Kit K-004
by Olympus Medical Systems Corporation
Disposable Emr Kit K-004 is a Class II device made by Olympus Medical Systems Corporation, listed in FDA GUDID since 21 Sep 2018 (UDI-DI 04953170048593), 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 | Number04953170048593 | Date21 Sep 2018 | StatusListed |
Official records
- AccessGUDID record 04953170048593
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Disposable Emr Kit
- Generic name
- Endoscopic electrosurgical submucosal lift/resection set
- Model / reference
- K-004
- Primary DI / UDI-DI
- 04953170048593
- FDA product code
- FDS
- GMDN term
- Endoscopic electrosurgical submucosal lift/resection set
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
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