AccessGUDID - DEVICE: A.M.I. FasciaCutter Disposable Instrument (EAMIAFC1000)

GUDID

Device Identifier (DI) Information

Brand Name: A.M.I. FasciaCutter Disposable Instrument
Version or Model: AFC 100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AFC 100
Company Name: AMI Agency for Medical Innovations GmbH

Primary DI Number: EAMIAFC1000
Issuing Agency: HIBCC
Commercial Distribution End Date: August 24, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 303655286 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47569	Scalpel, single-use	A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZT	Cutter, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 13 Millimeter
Length: 195 Millimeter

Device Record Status

Public Device Record Key: fba0548c-9f1f-4f07-9d12-c189a721d334
Public Version Date: October 03, 2022
Public Version Number: 3
DI Record Publish Date: November 28, 2018