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SmartRelease Endoscopic Soft Tisssue Release, Onyx Blade Assembly
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 83030-6-CE510(k) K113128
Identity
- Trade Name
- SmartRelease Endoscopic Soft Tisssue Release, Onyx Blade Assembly EUDAMEDMicroAire® FDA UDI
- Generic Name
- Hand ligament surgical release instrument FDA UDI
- Device Name
- Blade Assembly EUDAMEDLow Profile (LP) Blade Assembly 6pk FDA UDI
- Model / Reference
- 83030-6-CE EUDAMED83030-6 FDA UDI
- Description
- Low Profile (LP) Blade Assembly 6pk FDA UDI
Identifiers
- Catalog Number
- 83030-6-CE FDA UDI
- Primary DI / UDI-DI
- 00847399015860 EUDAMEDFDA UDI
- Basic UDI-DI
- 08473990SMARTRELEASENA EUDAMED
- Unit of Use DI
- 00847399015853 EUDAMED
- FDA Product Code
- EMF FDA UDI
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Hand ligament surgical release instrument FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
Category: Cranial bur, single-use
SmartRelease Endoscopic Soft Tisssue Release, Onyx Blade Assembly by MicroAire Surgical Instruments LLC — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA…
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113128 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08473990SMARTRELEASENA | Class IIa | Active |
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Manufacturer
- Manufacturer
- MicroAire Surgical Instruments LLC
- EUDAMED SRN
- US-MF-000004063
- FDA Applicant
- Microaire Surgical Instruments, LLC
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (3)
- EUDAMED 7685e965-9391-4987-a76c-5573d1df553f 85 fields · synced Jun 18, 2026
- FDA UDI ceb7de85-5355-43ae-8b1c-bb4547263471 34 fields · synced May 30, 2026
- FDA 510(k) K113128 1 fields · synced May 18, 2026