Identity
- Trade Name
- Sontec Titanium Cutting Block FDA UDI
- Generic Name
- Surgical cutting/shaping board, reusable FDA UDI
- Device Name
- Sontec Titanium Cutting Block With Grid 85 Millimeters X 55 Millimeters X 10 Millimeters FDA UDI
- Model / Reference
- 350-8454T FDA UDI
- Description
- Sontec Titanium Cutting Block With Grid 85 Millimeters X 55 Millimeters X 10 Millimeters FDA UDI
Identifiers
- Catalog Number
- 350-8454T FDA UDI
- Primary DI / UDI-DI
- 00192896107168 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical cutting/shaping board, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Category: Surgical cutting/shaping board, reusable
Sontec Titanium Cutting Block by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical cutting/shaping board, reusable.
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- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- Preparation tray, stainless steel — Spiggle & Theis Medizintechnik GmbH · Class I
- Gyrus ACMI — Gyrus Acmi, Inc. · Class I
- V. Mueller — STERIS CORPORATION · 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 |
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Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 8363fd0d-36b1-462f-b830-258e98cf5c26 35 fields · synced May 30, 2026