Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Ocular hook/spatula/manipulator, reusable FDA UDI
- Device Name
- Rowen phaco spatula, 5 5/8'', double-ended, angled shafts, 9mm from bend to tip, Rosen chopper, 60 degrees interior cutting edge, blunt tip, 7.0mm from bend to tip, Bechert ''Y'' shaped nucleus rotator, round handle FDA UDI
- Model / Reference
- Rowen phaco spatula FDA UDI
- Description
- Rowen phaco spatula, 5 5/8'', double-ended, angled shafts, 9mm from bend to tip, Rosen chopper, 60 degrees interior cutting edge, blunt tip, 7.0mm from bend to tip, Bechert ''Y'' shaped nucleus rotator, round handle FDA UDI
Identifiers
- Catalog Number
- 6892E FDA UDI
- Primary DI / UDI-DI
- 00190660012021 FDA UDI
- FDA Product Code
- HND FDA UDI
- GMDN Term
- Ocular hook/spatula/manipulator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
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: Ocular hook/spatula/manipulator, reusable
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ocular hook/spatula/manipulator, reusable.
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- Diamatrix — Diamatrix · Class I
- Rumex — Rumex International Co. · Class I
- Ophthalmic Spatula — CILITA Ltd. · Class I
- Rumex — Rumex International Co. · Class I
- Sklar — Sklar Corporation · Class I
- Surgical Direct — SURGICAL DIRECT, 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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI eb884c6d-b311-4581-b433-a41776e4c9d2 35 fields · synced May 30, 2026