Identity
- Trade Name
- AESCULAP FDA UDI
- Generic Name
- Burring power tool attachment FDA UDI
- Device Name
- HI-LINE STRAIGHT HANDPIECE EXTRA SHORT FDA UDI
- Model / Reference
- GB529R FDA UDI
- Description
- HI-LINE STRAIGHT HANDPIECE EXTRA SHORT FDA UDI
Identifiers
- Catalog Number
- GB529R FDA UDI
- Primary DI / UDI-DI
- 04038653004041 FDA UDI
- FDA Product Code
- HBB FDA UDIHWE FDA UDI
- GMDN Term
- Burring power tool attachment FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4370 FDA UDI878.4820 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Aesculap by Aesculap, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Aesculap, Inc.
Sources (1)
- FDA UDI 4daa5a58-37e0-4637-9050-d1c003bcde05 36 fields · synced Jun 1, 2026