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Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name
Ambler Surgical FDA UDI
Generic Name
Ophthalmic surgical irrigation/infusion/aspiration handle, reusable FDA UDI
Device Name
Bimanual aspiration tip, 21 gauge, curved shaft, 0.3mm single aspiration port, for use with Ambler # 7650E FDA UDI
Model / Reference
Bimanual aspiration tip FDA UDI
Description
Bimanual aspiration tip, 21 gauge, curved shaft, 0.3mm single aspiration port, for use with Ambler # 7650E FDA UDI

Identifiers

Catalog Number
7657E FDA UDI
Primary DI / UDI-DI
00190660087715 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
Sterilization Method
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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ambler Surgical, LLC

Sources (1)

  • FDA UDI d8eb0904-98da-4746-9396-98f5ce85e711 35 fields · synced Jun 6, 2026