Identity
- Trade Name
- JMU FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
- Device Name
- JMU NITI ROTARY FILES, PT-G SUPER FILES, F1(25mm), Sterilized Packing, 6pcs/Pk, #D-SUPER FILES (GOLD) FDA UDI
- Model / Reference
- 22801008 FDA UDI
- Description
- JMU NITI ROTARY FILES, PT-G SUPER FILES, F1(25mm), Sterilized Packing, 6pcs/Pk, #D-SUPER FILES (GOLD) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840456213131 FDA UDI
- FDA Product Code
- EKS FDA UDI
- GMDN Term
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rotary/reciprocating endodontic file/rasp, single-use
Jmu by Jmu Dental, 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
- Jmu Dental, Inc
Sources (1)
- FDA UDI 189eea07-4698-431c-b4b9-d44e4781afec 33 fields · synced May 30, 2026