AccessGUDID - DEVICE: A.M.I. Aigner Gastric Band Cutting Wires DLU (EAMIGBC3640)

GUDID

Device Identifier (DI) Information

Brand Name: A.M.I. Aigner Gastric Band Cutting Wires DLU
Version or Model: GBC 364
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GBC 364
Company Name: AMI Agency for Medical Innovations GmbH

Primary DI Number: EAMIGBC3640
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 303655286 *Terms of Use

Device Description: Cutting wire for cutting a migrated silicone gastric band

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?
11290	Open-surgery dissector	A hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable 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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 3.8 Meter
Outer Diameter: 0.5 Millimeter

Device Record Status

Public Device Record Key: 926c4f01-887d-4aef-ac14-0fb496e3229d
Public Version Date: January 02, 2023
Public Version Number: 3
DI Record Publish Date: November 28, 2018