Amnicot

FDA UDI

Class I (US FDA UDI)

by Go Medical Industries Pty. Ltd.

Identity

Trade Name: Amnicot FDA UDI
Generic Name: Amniotic membrane perforator, single-use FDA UDI
Model / Reference: Amnicot English FDA UDI

Identifiers

Catalog Number: ACD01-E FDA UDI
Primary DI / UDI-DI: 09350902000174 FDA UDI
510(k) Number: K850758 FDA UDI
FDA Product Code: HGE FDA UDI
GMDN Term: Amniotic membrane perforator, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.4530 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Amniotic membrane perforator, single-use

Amnicot by Go Medical Industries Pty. Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Amniotic membrane perforator, single-use.

Centurion — Centurion Medical Products · Class I
ObstiHook — COOK INCORPORATED · Class I
Amnihook Amniotic Membrane Perforator — Aspen Surgical Products, Inc. · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
BUSSE HOSPITAL DISPOSABLES — ROBERT BUSSE & CO., INC. · Class I
Amnicot — GO MEDICAL INDUSTRIES PTY. LTD. · Class I

Cleared under the same submission

K850758 also covers:

Amnicot — GO MEDICAL INDUSTRIES PTY. LTD.

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: Go Medical Industries Pty. Ltd.

Sources (1)

FDA UDI 50eafec5-2799-4281-baa8-55c499b33e04 34 fields · synced May 30, 2026