Identity
- Trade Name
- ECLIPSE PASSIVE FDA UDI
- Generic Name
- Self-ligating orthodontic bracket FDA UDI
- Device Name
- 022 U3L ECLIPSE PASSIVE SLB ROTH -2T HK (5) FDA UDI
- Model / Reference
- 463-122 FDA UDI
- Description
- 022 U3L ECLIPSE PASSIVE SLB ROTH -2T HK (5) FDA UDI
Identifiers
- Catalog Number
- 463-122 FDA UDI
- Primary DI / UDI-DI
- D90946312215 FDA UDI
- FDA Product Code
- EJF FDA UDI
- GMDN Term
- Self-ligating orthodontic bracket FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Category: Self-ligating orthodontic bracket
Eclipse Passive by Ortho Arch Company 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 Arch Company Inc
Sources (1)
- FDA UDI d747d8c5-7c74-4d98-8b37-007fa24100fa 34 fields · synced May 30, 2026