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Me-92
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5071-178Ref 5071-195Ref 5071-166Ref 5071-167Ref 5071-142
Identity
- Trade Name
- ME-92 EUDAMEDFDA UDI
- Generic Name
- Surgical saw blade, oscillating, single-use FDA UDI
- Device Name
- Orthopedic, Non-active, Handpiece Blade, Oscillating EUDAMEDOSCILLATOR BLADE, ME-92 COATED, 19.5 X 90 X 1.2 MM (.047") FDA UDIOSCILLATOR BLADE, ME-92 COATED, 19.5 X 80 X 0.9 MM (.035") FDA UDIOSCILLATOR BLADE, ME-92 COATED, 32 X 64 X 0.8 MM (.031") FDA UDIOSCILLATOR BLADE, ME-92 COATED, 25.4 X 90 X 1.2 MM (.047") FDA UDIOSCILLATOR BLADE, ME-92 COATED, 19.5 X 80 X 0.8 MM (.031") FDA UDI
- Model / Reference
- 5071-178 EUDAMED5071-195 EUDAMED5071-166 EUDAMED5071-167 EUDAMED5071-142 EUDAMED00507116700 FDA UDI00507119500 FDA UDI00507116600 FDA UDI00507114200 FDA UDI00507117800 FDA UDI
- Description
- OSCILLATOR BLADE, ME-92 COATED, 19.5 X 90 X 1.2 MM (.047") FDA UDIOSCILLATOR BLADE, ME-92 COATED, 19.5 X 80 X 0.9 MM (.035") FDA UDIOSCILLATOR BLADE, ME-92 COATED, 32 X 64 X 0.8 MM (.031") FDA UDIOSCILLATOR BLADE, ME-92 COATED, 25.4 X 90 X 1.2 MM (.047") FDA UDIOSCILLATOR BLADE, ME-92 COATED, 19.5 X 80 X 0.8 MM (.031") FDA UDI
Identifiers
- Catalog Number
- 5071-167 FDA UDI5071-195 FDA UDI5071-166 FDA UDI5071-142 FDA UDI5071-178 FDA UDI
- Primary DI / UDI-DI
- 10845854002339 EUDAMEDFDA UDI10845854003787 EUDAMEDFDA UDI10845854002322 EUDAMEDFDA UDI10845854000571 EUDAMEDFDA UDI10845854004142 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854002339 EUDAMEDB-10845854003787 EUDAMEDB-10845854002322 EUDAMEDB-10845854000571 EUDAMEDB-10845854004142 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
Dimensions & Sizes
- Size
- Height — 0.047 Inch FDA UDIHeight — 1.2 Millimeter FDA UDIWidth — 19.5 Millimeter FDA UDILength — 90 Millimeter FDA UDIHeight — 0.035 Inch FDA UDIHeight — 0.9 Millimeter FDA UDILength — 80 Millimeter FDA UDIHeight — 0.031 Inch FDA UDIWidth — 32 Millimeter FDA UDIHeight — 0.8 Millimeter FDA UDILength — 64 Millimeter FDA UDIWidth — 25.4 Millimeter FDA UDI
Me-92 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-10845854002339 | 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 (15)
- EUDAMED bcdf4cf4-85ce-47fc-9558-ad316f1ea365 61 fields · synced Aug 2, 2026
- EUDAMED e2139472-33ca-41fa-af95-c9a3f2a5c54e 61 fields · synced May 16, 2026
- EUDAMED 9f53d6dc-94ea-4d4c-80e7-2f3049b0602a 61 fields · synced May 17, 2026
- EUDAMED 715580d6-6ec9-4674-8906-8358015102be 61 fields · synced May 17, 2026
- EUDAMED 35be38ef-94f6-45cc-8e8d-8ea944fa3a8c 61 fields · synced May 17, 2026
- FDA UDI 2025e440-2892-4b19-91aa-b97285ee8625 36 fields · synced May 30, 2026
- FDA UDI 9f0068f2-98a4-4d39-8e8d-64cd13633021 36 fields · synced May 30, 2026
- FDA UDI 47bb648d-ef50-414e-a5a8-07b526393552 36 fields · synced May 30, 2026
- FDA UDI fc32117f-4e2c-47d4-bfda-2887d00eeafb 36 fields · synced May 30, 2026
- FDA UDI 45bbb921-284b-4742-b1a5-b0218ab41fcc 36 fields · synced May 30, 2026
- EUDAMED 910e1b9c-ac3e-4214-baf5-649915fea493 61 fields · synced Jul 11, 2026
- EUDAMED 7978d272-e106-4f49-8264-75348b7dbc70 61 fields · synced Jul 12, 2026
- EUDAMED d67c6771-d8f9-4240-be18-fa14eaefa588 61 fields · synced Jul 21, 2026
- EUDAMED 0cfb3063-775b-47d4-9faa-a7a5e2854a80 61 fields · synced Jul 25, 2026
- EUDAMED 2ff4d61e-adca-4755-8460-9c31590ff062 61 fields · synced Aug 2, 2026