Identity
- Trade Name
- BurSafe Bur Holders- True Blue FDA UDI
- Generic Name
- Surgical instrument interim-placement holder, reusable FDA UDI
- Device Name
- Bur storage, sterilization, and retrieval easier and safer than ever. Unique design stores six burs horizontally, and removal is as simple as pressing down on one end. Two models accommodate both FG and RA Burs and side easily into small, flat sterilization pouches. Fully sterilization to 375 degree F. FDA UDI
- Model / Reference
- 53C9060 FDA UDI
- Description
- Bur storage, sterilization, and retrieval easier and safer than ever. Unique design stores six burs horizontally, and removal is as simple as pressing down on one end. Two models accommodate both FG and RA Burs and side easily into small, flat sterilization pouches. Fully sterilization to 375 degree F. FDA UDI
Identifiers
- Catalog Number
- 70-39730-BLU FDA UDI
- Primary DI / UDI-DI
- 00723896006009 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Surgical instrument interim-placement holder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument interim-placement holder, reusable
BurSafe Bur Holders- True Blue by Practicon, 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
- Practicon, Inc.
Sources (1)
- FDA UDI e5251bcb-9e69-4e39-bcde-dc85b8067a57 34 fields · synced May 30, 2026