Identity
- Trade Name
- M-TWO INSTRUMENT FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
- Device Name
- M-TWO INSTRUMENT 15/.05 31 MM, 6 PCS FDA UDI
- Model / Reference
- M2150531 FDA UDI
- Description
- M-TWO INSTRUMENT 15/.05 31 MM, 6 PCS FDA UDI
Identifiers
- Catalog Number
- M2150531 FDA UDI
- Primary DI / UDI-DI
- D7700485793 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rotary/reciprocating endodontic file/rasp, single-use
M-Two Instrument by Sweden & Martina 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
- Sweden & Martina Inc
Sources (1)
- FDA UDI 42132f0c-6a41-4ee4-b95a-6b8c755e3d27 35 fields · synced May 30, 2026