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Amnihook Amniotic Membrane Perforator

FDA UDI

Class I (US FDA UDI)

by Aspen Surgical Products, Inc.

Identity

Trade Name
Amnihook Amniotic Membrane Perforator FDA UDI
Generic Name
Amniotic membrane perforator, single-use FDA UDI
Device Name
Stork AmniHook, Amniotic Membrane Perforator, Yellow, Sterile, 1/pouch, 100pouches/box FDA UDI
Model / Reference
9601 FDA UDI
Description
Stork AmniHook, Amniotic Membrane Perforator, Yellow, Sterile, 1/pouch, 100pouches/box FDA UDI

Identifiers

Primary DI / UDI-DI
00840113231485 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Amniotic membrane perforator, single-use

Amnihook Amniotic Membrane Perforator by Aspen Surgical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Amniotic membrane perforator, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aspen Surgical Products, Inc.

Sources (1)

  • FDA UDI 14590b08-189f-4824-bf8d-f63276f1202a 33 fields · synced Jun 9, 2026