Identity
- Trade Name
- PEAK MEDICAL FDA UDI
- Generic Name
- Dental root separator FDA UDI
- Device Name
- MEDICAL GRADE STAINLESS STEEL COLANDER 8" FDA UDI
- Model / Reference
- 33-SM Colander FDA UDI
- Description
- MEDICAL GRADE STAINLESS STEEL COLANDER 8" FDA UDI
Identifiers
- Primary DI / UDI-DI
- G45333SMCOLANDAR0 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Dental root separator 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
No
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
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: Dental root separator
Peak Medical by PEAK MEDICAL Distribution Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Ambler Surgical — Ambler Surgical, LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- AESCULAP — AESCULAP, INC. · Class I
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
- PEAK MEDICAL Distribution Inc
Sources (1)
- FDA UDI 7694df2a-8e61-4e14-9c42-59c28020b32e 33 fields · synced Jun 1, 2026