Identity
- Trade Name
- Midway Select FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Device Name
- Stainless Steel K Files (Hand), Size # 35, Length 31 mm FDA UDI
- Model / Reference
- 002-0418 FDA UDI
- Description
- Stainless Steel K Files (Hand), Size # 35, Length 31 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10843717104138 FDA UDI
- FDA Product Code
- EKS FDA UDI
- GMDN Term
- Manual endodontic file/rasp, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Midway Select by Midway Dental Supply, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Midway Dental Supply, Llc
Sources (1)
- FDA UDI 3c2a0bfc-7043-4f3a-92a1-6b544fcce02a 34 fields · synced May 31, 2026