Identity
- Trade Name
- MicroAire® FDA UDI
- Generic Name
- Bone file/rasp, reciprocating, single-use FDA UDI
- Device Name
- LARGE TEAR RASP, 7mm X 12.7mm FDA UDI
- Model / Reference
- SR-51-081 FDA UDI
- Description
- LARGE TEAR RASP, 7mm X 12.7mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847399012043 FDA UDI
- FDA Product Code
- HTR FDA UDI
- GMDN Term
- Bone file/rasp, reciprocating, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 7 Millimeter FDA UDILength — 12.7 Millimeter FDA UDI
MicroAire® by MicroAire Surgical Instruments LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- MicroAire Surgical Instruments LLC
Sources (1)
- FDA UDI 0b94d5f2-0b1c-49f0-b76e-79fe0da1a16c 35 fields · synced Jun 9, 2026