Identity
- Trade Name
- MClass EUDAMEDFDA UDI
- Generic Name
- Surgical saw blade, oscillating, single-use FDA UDI
- Device Name
- Orthopedic, Non-active, Handpiece Blade, Oscillating EUDAMEDMCLASS OSCILLATING SAW BLADE 19 X 1.00 (0.039") X 90 MM FDA UDI
- Model / Reference
- T190-100-90 EUDAMEDFDA UDI
- Description
- MCLASS OSCILLATING SAW BLADE 19 X 1.00 (0.039") X 90 MM FDA UDI
Identifiers
- Catalog Number
- T190-100-90 FDA UDI
- Primary DI / UDI-DI
- 10845854020982 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854020982 EUDAMED
- FDA Product Code
- GFA FDA UDI
- EMDN Code
- K030203 ARTHROSCOPY BLADES, SINGLE-USE EUDAMED
- GMDN Term
- Surgical saw blade, oscillating, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MClass by Conmed Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10845854020982 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 83cb1d0e-2543-4675-aecf-96ed316b6b72 61 fields · synced May 30, 2026
- FDA UDI a2a087a8-bfbd-4048-afb1-106fa9fe3b7b 36 fields · synced May 30, 2026