Identity
- Trade Name
- SILICONE MAT FDA UDI
- Generic Name
- General-purpose bowl, reusable FDA UDI
- Device Name
- FOR 55-348-00-01 FDA UDI
- Model / Reference
- 55-348-01-01 FDA UDI
- Description
- FOR 55-348-00-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888118086037 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- General-purpose bowl, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General-purpose bowl, reusable
Silicone Mat by KLS-Martin L.P. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose bowl, reusable.
- BMT Medizintechnik GmbH — BMT Medizintechnik GmbH · Class I
- METAL INSTRUMENT TRAY — SONTEC INSTRUMENTS, INC. · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Gimmi — Gimmi GmbH · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- CATHETER TRAY DOME COVER — SONTEC INSTRUMENTS, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- KLS-Martin L.P.
Sources (1)
- FDA UDI 262a6b0e-e39e-44b8-8624-ed1d7fdff2b6 34 fields · synced May 30, 2026