Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Ophthalmic curette, reusable FDA UDI
Device Name: Ambler capsule polishing sweeper/curette, 5 7/8”, double-ended, for pristine cleansing of the capsule for reduced PCO, to liberate lec’s from the capsule rim and remove cortical strands, reduce inflammation and lessen capsular fibrosis, round handle FDA UDI
Model / Reference: Ambler capsule polishing sweeper/curette FDA UDI
Description: Ambler capsule polishing sweeper/curette, 5 7/8”, double-ended, for pristine cleansing of the capsule for reduced PCO, to liberate lec’s from the capsule rim and remove cortical strands, reduce inflammation and lessen capsular fibrosis, round handle FDA UDI

Identifiers

Catalog Number: 5475E FDA UDI
Primary DI / UDI-DI: 00190660008024 FDA UDI
FDA Product Code: HNZ FDA UDI
GMDN Term: Ophthalmic curette, 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic curette, reusable

Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 a2f65f07-07a5-44eb-931a-931f364b22e3 35 fields · synced May 29, 2026