Identity
- Trade Name
- Brasseler USA FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, reusable FDA UDI
- Device Name
- UNIV OF MONTREAL ENDO COMP 1P FDA UDI
- Model / Reference
- 5008387U0 FDA UDI
- Description
- UNIV OF MONTREAL ENDO COMP 1P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887919496847 FDA UDI
- GMDN Term
- Rotary/reciprocating endodontic file/rasp, reusable FDA UDI
Classification
- Commercial Distribution
- 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
Yes
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
Category: Rotary/reciprocating endodontic file/rasp, reusable
Brasseler USA by Peter Brasseler Holdings, LLC — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Peter Brasseler Holdings, LLC
Sources (1)
- FDA UDI a9475289-4262-4d39-a9b8-e3ccf4d700f4 33 fields · synced Jun 8, 2026