AccessGUDID - DEVICE: MicroFrance® (10381780539711)

GUDID

Device Identifier (DI) Information

Brand Name: MicroFrance®
Version or Model: MCEN81-C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCEN81-C
Company Name: INTEGRA MICROFRANCE

Primary DI Number: 10381780539711
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276593071 *Terms of Use
Previous DI: 10381780103899

Device Description: MicroFrance® Sleeve for Comeg telescope

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?
58098	Internally-anchored endoscopic retractor sleeve	A non-sterile, interchangeable, tubular device (sleeve) designed to be attached (screwed or snapped) to a dedicated applier and perform through a compatible endoscopic instrument (e.g., an access port) to insert an internally-anchored endoscopic retractor for hands-free retraction of a selected internal organ during a laparoscopic or thoracoscopic procedure. It is available in various diameters and lengths to accommodate various size internal retractors; after completion of the procedure it is used for extraction of the retractor. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCB	TUBE, TONSIL SUCTION

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
Angle: 30 degree
Outer Diameter: 4 Millimeter

Device Record Status

Public Device Record Key: c067eecc-7b6b-4a73-8ad8-e45bc670b403
Public Version Date: June 06, 2024
Public Version Number: 1
DI Record Publish Date: May 29, 2024