Identity
- Trade Name
- ORTHODONTIC INSTRUMENTS FDA UDI
- Generic Name
- Orthodontic metal band pusher FDA UDI
- Device Name
- BAND PUSHER/SEATER INSTRUMENT FDA UDI
- Model / Reference
- 4150-976 FDA UDI
- Description
- BAND PUSHER/SEATER INSTRUMENT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190707064747 FDA UDI
- FDA Product Code
- EMN FDA UDI
- GMDN Term
- Orthodontic metal band pusher 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
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
No
FDA UDI
Category: Orthodontic metal band pusher
Orthodontic Instruments by Ortho Organizers, 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
- Ortho Organizers, Inc.
Sources (1)
- FDA UDI b288ba95-01ed-4658-96dd-02d2a6fd8501 33 fields · synced Jun 9, 2026