Identity
- Trade Name
- Reverse Pull Headgear(Face Mask), Middle, Blue FDA UDI
- Generic Name
- Orthodontic extraoral headgear FDA UDI
- Model / Reference
- 5268-5002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973329326066 FDA UDI
- FDA Product Code
- KCR FDA UDI
- GMDN Term
- Orthodontic extraoral headgear FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3220 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
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: Orthodontic extraoral headgear
Reverse Pull Headgear(Face Mask), Middle, Blue by Astar Orthodontics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic extraoral headgear.
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- G&H COLOR COATED FACEBOW — G&H Wire Company, Inc. · Class II
- 3M™ — 3M UNITEK CORPORATION · Class II
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
- Astar Orthodontics Inc.
Sources (1)
- FDA UDI d6f32a9f-c15d-4739-b07d-93da546310fd 32 fields · synced May 31, 2026