AccessGUDID - DEVICE: MicroFrance® (10381780538530)

GUDID

Device Identifier (DI) Information

Brand Name: MicroFrance®
Version or Model: 7771
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7771
Company Name: INTEGRA MICROFRANCE

Primary DI Number: 10381780538530
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276593071 *Terms of Use
Previous DI: 10381780089018

Device Description: MicroFrance® Albertini trocar for drain

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:	No
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?
61424	Laparoscopic trocar blade, reusable	A rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTE	TROCAR, ENT

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
Device Size Text, specify: 03 mm
Device Size Text, specify: 160 mm

Device Record Status

Public Device Record Key: 523efecb-6e30-4952-b645-4849ac7e9e24
Public Version Date: June 06, 2024
Public Version Number: 1
DI Record Publish Date: May 29, 2024