Identity
- Trade Name
- PACK Precision Allograft Cartilage Kit FDA UDI
- Generic Name
- Drilling power tool attachment, basic FDA UDI
- Device Name
- CORING DRILL, 28mm FDA UDI
- Model / Reference
- PAC-A2528 FDA UDI
- Description
- CORING DRILL, 28mm FDA UDI
Identifiers
- Catalog Number
- PAC-A2528 FDA UDI
- Primary DI / UDI-DI
- 00846468004040 FDA UDI
- FDA Product Code
- GFG FDA UDI
- GMDN Term
- Drilling power tool attachment, basic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
PACK Precision Allograft Cartilage Kit by Pioneer Surgical Technology, Inc. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pioneer Surgical Technology, Inc.
Sources (1)
- FDA UDI 88e9284e-302f-43c9-9a98-ba09d93e3008 37 fields · synced Jun 6, 2026