Identity
- Trade Name
- Mimix, STEALTH FDA UDI
- Generic Name
- Arthroscopic shaver system blade, single-use FDA UDI
- Device Name
- MIMIX 35° FRR STEALTH, 3.5 MM FDA UDI
- Model / Reference
- LE-35FRP FDA UDI
- Description
- MIMIX 35° FRR STEALTH, 3.5 MM FDA UDI
Identifiers
- Catalog Number
- LE-35FRP FDA UDI
- Primary DI / UDI-DI
- 20845854649203 FDA UDI
- FDA Product Code
- GFA FDA UDI
- GMDN Term
- Arthroscopic shaver system blade, single-use 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
Dimensions & Sizes
- Size
- Length — 3.5 Millimeter FDA UDIAngle — 35 degree FDA UDI
Category: Arthroscopic shaver system blade, single-use
Mimix, STEALTH by Conmed Corporation — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (2)
- FDA UDI 2288a09f-ac89-43b9-8559-e230ef126b2a 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026