Identity
- Trade Name
- Smillie Meniscus Knife FDA UDI
- Generic Name
- Meniscus knife FDA UDI
- Device Name
- Smillie Meniscus Knife Curved V Tip FDA UDI
- Model / Reference
- 350-838 FDA UDI
- Description
- Smillie Meniscus Knife Curved V Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896105737 FDA UDI
- FDA Product Code
- HTS FDA UDI
- GMDN Term
- Meniscus knife 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
Dimensions & Sizes
- Size
- Length — 8 Inch FDA UDI
Category: Meniscus knife
Smillie Meniscus Knife by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Meniscus knife.
- ACUFEX — Smith & Nephew, Inc. · Class I
- Beaver® — Beaver-Visitec International, Inc. · Class I
- ACUFEX — Smith & Nephew, Inc. · Class I
- ACUFEX — Smith & Nephew, Inc. · Class I
- ACUFEX — Smith & Nephew, Inc. · Class I
- ACUFEX — Smith & Nephew, Inc. · Class I
- ACUFEX — Smith & Nephew, Inc. · Class I
- ACUFEX — Smith & Nephew, 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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI ae856fe5-6570-4054-97bd-a3bf0b9b395a 35 fields · synced May 31, 2026