Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Ophthalmic surgical irrigation/infusion/aspiration handle, reusable FDA UDI
- Device Name
- McIntyre handpiece for aspirating or irrigating, 3'' length, Luer connector and narrow tubing connector, autoclavable plastic FDA UDI
- Model / Reference
- McIntyre handpiece for aspirating or irrigating FDA UDI
- Description
- McIntyre handpiece for aspirating or irrigating, 3'' length, Luer connector and narrow tubing connector, autoclavable plastic FDA UDI
Identifiers
- Catalog Number
- 6794E FDA UDI
- Primary DI / UDI-DI
- 00190660083021 FDA UDI
- FDA Product Code
- KYG FDA UDI
- GMDN Term
- Ophthalmic surgical irrigation/infusion/aspiration handle, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4360 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: Ophthalmic surgical irrigation/infusion/aspiration handle, reusable
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical irrigation/infusion/aspiration handle, reusable.
- Stephens Instruments — KRISHNA IMPORTS INC · Class I
- Irrigation and Aspiration — AURORA SURGICAL, LLC · Class I
- Volk Infusion Handle — VOLK OPTICAL INC. · Class I
- Bi-Manual Irrigation/Aspiration — AURORA SURGICAL, LLC · Class I
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- Cannulas — AURORA SURGICAL, LLC · Class I
- Irrigation and Aspiration — AURORA SURGICAL, LLC · Class I
- Anodyne Surgical — Psi/Eye-Ko, 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 8d4eb340-a2cf-4ea2-95d1-58641b0c8e5e 35 fields · synced May 30, 2026