AccessGUDID - DEVICE: MicroFrance® (10381780103554)

GUDID

Device Identifier (DI) Information

Brand Name: MicroFrance®
Version or Model: MCEN68BDG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCEN68BDG
Company Name: INTEGRA MICROFRANCE

Primary DI Number: 10381780103554
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276593071 *Terms of Use

Device Description: MicroFrance® De Gabory curette insert straight and tube WL 120 mm for handle MCEN728DG

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?
47525	Paranasal sinus curette	A slender, hand-held, manual surgical instrument designed for scraping and/or excising tissue from one of the paranasal sinuses (i.e., frontal, sphenoidal, ethmoidal, maxillary). The distal end of the instrument is finished in an appropriate shape (e.g., cup-, ring-, spoon-like) according to the procedure to be performed; the device is typically made of high-grade stainless steel and is available in a variety of shapes and sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTF	CURETTE

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
No Device Sizes

Device Record Status

Public Device Record Key: 5dbf77d4-6bda-4773-b162-2ef8f69e3361
Public Version Date: May 11, 2023
Public Version Number: 4
DI Record Publish Date: January 10, 2018