Identity
- Trade Name
- Galaxy FDA UDI
- Generic Name
- Dental abrasive strip, reusable FDA UDI
- Device Name
- Perforated Strips Wide Kit 9/pk 3 each type 3.75mm wide FDA UDI
- Model / Reference
- 88500 FDA UDI
- Description
- Perforated Strips Wide Kit 9/pk 3 each type 3.75mm wide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190730009739 FDA UDI
- FDA Product Code
- EHM FDA UDI
- GMDN Term
- Dental abrasive strip, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6010 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
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
Galaxy by Ortho Technology, 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
- Ortho Technology, Inc.
Sources (1)
- FDA UDI ad01f40b-164e-4d1f-a712-03889c3ec2e1 34 fields · synced Jun 8, 2026