Identity
- Trade Name
- Spandex Child FDA UDI
- Generic Name
- Dental cheek retractor, professional, reusable FDA UDI
- Device Name
- Dental Cheek/Lip Retractor FDA UDI
- Model / Reference
- 605455 FDA UDI
- Description
- Dental Cheek/Lip Retractor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00014081054555 FDA UDI
- FDA Product Code
- EIF FDA UDI
- GMDN Term
- Dental cheek retractor, professional, reusable 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Spandex Child by Hager Worldwide, Inc. — 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
- Hager Worldwide, Inc.
Sources (1)
- FDA UDI faae9620-cfbe-4a2b-97b6-660227723b37 35 fields · synced Jun 9, 2026