Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Ocular hook/spatula/manipulator, reusable FDA UDI
- Device Name
- Niksarli II IntraLase flap lifter/retreatment spatula, 4 1/2'', double-ended, 3.0mm long, 90 degrees angled tip, round handle, titanium FDA UDI
- Model / Reference
- Niksarli II IntraLase flap lifter/retreatment spatula FDA UDI
- Description
- Niksarli II IntraLase flap lifter/retreatment spatula, 4 1/2'', double-ended, 3.0mm long, 90 degrees angled tip, round handle, titanium FDA UDI
Identifiers
- Catalog Number
- 6952T FDA UDI
- Primary DI / UDI-DI
- 00190660175726 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.
- CARLSON DSEK SMOOTHER — DAUD JEE MFG. CO · Class I
- 57150 Spatula, Model Giessen — Bausch & Lomb GmbH · Class I
- 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 a8ede726-af5f-49a1-98fb-8a1811262995 35 fields · synced May 30, 2026