Identity
- Trade Name
- Henry Schein FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
- Device Name
- Endoflex NiTi File .06 21mm FDA UDI
- Model / Reference
- 5700569 FDA UDI
- Description
- Endoflex NiTi File .06 21mm FDA UDI
Identifiers
- Catalog Number
- 5700569 FDA UDI
- Primary DI / UDI-DI
- H65857005691 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
No
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
Yes
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, single-use
Henry Schein by Henry Schein, 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
- Henry Schein, Inc.
Sources (1)
- FDA UDI 9f2cda7b-e705-4936-9a3a-3289f07d822e 35 fields · synced May 30, 2026