Identity
- Trade Name
- Integra® Miltex® FDA UDI
- Generic Name
- Hand-held dental retractor FDA UDI
- Device Name
- Integra® Miltex® Cheek Retractor, 8", 1-1/4" Wide Swivel Blade FDA UDI
- Model / Reference
- 22-210 FDA UDI
- Description
- Integra® Miltex® Cheek Retractor, 8", 1-1/4" Wide Swivel Blade FDA UDI
Identifiers
- Catalog Number
- 22-210 FDA UDI
- Primary DI / UDI-DI
- 10381780424598 FDA UDI
- FDA Product Code
- EIG FDA UDI
- GMDN Term
- Hand-held dental retractor 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 8 Inch FDA UDI
Category: Hand-held dental retractor
Integra® Miltex® by Integra LifeSciences Production Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held dental retractor.
- Power Dental USA — Power Dental USA, Inc. · Class I
- Tatum Sinus Retractor — SUNCOAST DENTAL, INC. · Class I
- devemed — devemed GmbH · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- STOMA® — Storz am Mark GmbH · Class I
- DIOnavi. Scan Retractor Lower jaw — DIO Corporation · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI d4699c7e-a885-4850-99ac-544c8a2f650c 36 fields · synced Jun 9, 2026