A.M.I. FasciaCutter Disposable Instrument

FDA UDI

Class I (US FDA UDI)

by AMI Agency for Medical Innovations GmbH

Identity

Trade Name: A.M.I. FasciaCutter Disposable Instrument FDA UDI
Generic Name: Scalpel, single-use FDA UDI
Device Name: The A.M.I. FasciaCutter Disposable Instrument is a sterile, disposable scalpel that is used to for enlargement of trocar incisions. The instrument is used in conjunction with an A.M.I. TissueBag for retrieval of specimen bags. The A.M.I. Fascia Cutter Disposable Instrument allows for easy removal of specimens in order to avoid risk of damaging the specimen bag while enlarging the trocar incision. FDA UDI
Model / Reference: AFC 100 FDA UDI
Description: The A.M.I. FasciaCutter Disposable Instrument is a sterile, disposable scalpel that is used to for enlargement of trocar incisions. The instrument is used in conjunction with an A.M.I. TissueBag for retrieval of specimen bags. The A.M.I. Fascia Cutter Disposable Instrument allows for easy removal of specimens in order to avoid risk of damaging the specimen bag while enlarging the trocar incision. FDA UDI

Identifiers

Catalog Number: AFC 100 FDA UDI
Primary DI / UDI-DI: EAMIAFC1000 FDA UDI
FDA Product Code: FZT FDA UDI
GMDN Term: Scalpel, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

Yes

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Dimensions & Sizes

Size: Outer Diameter — 13 Millimeter FDA UDI
Length — 195 Millimeter FDA UDI

A.M.I. FasciaCutter Disposable Instrument by AMI Agency for Medical Innovations GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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: AMI Agency for Medical Innovations GmbH

Sources (1)

FDA UDI fba0548c-9f1f-4f07-9d12-c189a721d334 36 fields · synced May 30, 2026