Identity
- Trade Name
- Optiview FDA UDI
- Generic Name
- Self-retaining surgical retractor, reusable FDA UDI
- Device Name
- OPTIVIEW STD UNIV LIP and CHEEK RETRACTOR - 2PK FDA UDI
- Model / Reference
- 716-0050 FDA UDI
- Description
- OPTIVIEW STD UNIV LIP and CHEEK RETRACTOR - 2PK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989059977 FDA UDI
- FDA Product Code
- EIG FDA UDI
- GMDN Term
- Self-retaining surgical retractor, reusable 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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Self-retaining surgical retractor, reusable
Optiview by Ormco Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Self-retaining surgical retractor, reusable.
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Symmetry Cloward — SYMMETRY SURGICAL INC. · Class II
- Life Instruments — Life Instrument Corporation · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- SELF RETAINING CORONOID RETRACTOR CHAIN WITH RINGS — W.H. Holden, Inc. · Class I
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
- Ormco Corporation
Sources (1)
- FDA UDI dacf80d3-8e89-40c1-b11b-ea70ab8505c4 34 fields · synced Jun 9, 2026