Identity
- Trade Name
- SMARTGUARD MICRO100 FDA UDI
- Generic Name
- Surgical instrument guard, reusable FDA UDI
- Device Name
- SMARTGUARD MICRO 100 FDA UDI
- Model / Reference
- 00137511200 FDA UDI
- Description
- SMARTGUARD MICRO 100 FDA UDI
Identifiers
- Catalog Number
- 1375-112 FDA UDI
- Primary DI / UDI-DI
- 10845854033180 FDA UDI
- FDA Product Code
- GET FDA UDI
- GMDN Term
- Surgical instrument guard, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical instrument guard, reusable
Smartguard Micro100 by Conmed Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument guard, reusable.
- Legion — Smith & Nephew, Inc. · Class II
- Made-To-Order — TORNIER, INC. · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- Made-To-Order — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- Made-To-Order — TORNIER, INC. · Class I
- JOURNEY II — Smith & Nephew, Inc. · Class II
- LINK Instruments - Saw and drill guides — WALDEMAR LINK GmbH & Co. KG · Class I
- Tornier Perform — TORNIER, 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
- Conmed Corporation
Sources (1)
- FDA UDI 2227e660-8c15-4239-a415-a784e349fba2 36 fields · synced May 29, 2026