AccessGUDID - DEVICE: MicroFrance® (10381780540519)

GUDID

Device Identifier (DI) Information

Brand Name: MicroFrance®
Version or Model: MCO6M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCO6M
Company Name: INTEGRA MICROFRANCE

Primary DI Number: 10381780540519
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276593071 *Terms of Use
Previous DI: 10381780109778

Device Description: MicroFrance® MOM OVAL KNIFE, WITH IRRIGATION

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?
45003	ENT suction dissector	A hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JYO	KNIFE, EAR

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: 200 Millimeter
Outer Diameter: 2 Millimeter
Device Size Text, specify: 5mm Tip
Device Size Text, specify: 2 x 2

Device Record Status

Public Device Record Key: 5437a2f4-40f6-4ef2-b84e-c4c049b5cca1
Public Version Date: June 06, 2024
Public Version Number: 1
DI Record Publish Date: May 29, 2024