Identity
- Trade Name
- Avitus Pilot Hole Creator, Disposable - 11mm FDA UDI
- Generic Name
- Bone awl, single-use FDA UDI
- Device Name
- Disposable surgical instrument with 11mm tip for manually cutting a hole into bone allowing access to cancellous bone. FDA UDI
- Model / Reference
- PC-100 FDA UDI
- Description
- Disposable surgical instrument with 11mm tip for manually cutting a hole into bone allowing access to cancellous bone. FDA UDI
Identifiers
- Catalog Number
- PC-100 FDA UDI
- Primary DI / UDI-DI
- 00857373006067 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone awl, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Category: Bone awl, single-use
Avitus Pilot Hole Creator, Disposable - 11mm by Avitus Orthopaedics, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Avitus Orthopaedics, Inc
Sources (1)
- FDA UDI 0a4f3510-6c6b-4758-b20d-65dbe1d20516 35 fields · synced Jun 6, 2026