Premium Plus 653-19-LM
by Premium Plus International Limited
Premium Plus 653-19-LM is an instrument tray (FDA Class I; FDA product code FSM, Tray, Surgical, Instrument) made by Premium Plus International Limited, listed in FDA GUDID since 30 Dec 2019 (UDI-DI D83865319LM4), registry data as of 22 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 | NumberD83865319LM4 | Date30 Dec 2019 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Premium Plus
- Generic name
- Instrument tray, reusable
- Model / reference
- 653-19-LM
- Primary DI / UDI-DI
- D83865319LM4
- FDA product code
- FSM
- GMDN term
- Instrument tray, reusable
- Device class
- Class I
- Regulation number
- 878.4800
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Instrument tray, reusable.
- METAL TRAY 13.8X6.6X1.8CM Saucer.M by TENS PLUS INDUSTRIAL COMPANY
- APEX Knee System KS-99917 by OMNIlife science, Inc.
- APEX Knee System KS-90081 by OMNIlife science, Inc.
- Stryker Universal Select Sterilization Tray System by Paragon Medical Inc.
- PST Corp. 6550B by Plastic Sterilizing Tray Corporation
- PST Corp. 6130A by Plastic Sterilizing Tray Corporation
- Instrument tray 400460 by Si-Bone Inc.
- Z5_m_c_mt leer by Z-Systems AG
- The Fassier-Duval Telescopic IM System FD-PEG-CEM-24 by ORTHOPEDIATRICS CANADA ULC