DANmed LMQ-228-033-S
by DANNORITZER Medizintechnik GmbH & Co. KG
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04251351113567 | Date5 Mar 2018 | StatusListed |
Recalls
-
- Terminated Z-0062-2019
The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- DANmed
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable
- Model / Ref / Catalog
- LMQ-228-033-S
- Description
- LAP-Instrument, Ø5mm, l=330mm, detach. Scissors METZENB, serr, cvd, d/a, Ti-Cut Plastic handle, w/o ratchet
- Primary DI / UDI-DI
- 04251351113567
- 510(k) Number
- FDA Product Code
- GEI
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, reusable
- Device Class
- Class II
- Regulation Number
- 878.4400
- GUDID distribution status
- Not in Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from DANNORITZER Medizintechnik GmbH & Co. KG
Properties
Other properties (12)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No