AccessGUDID - DEVICE: MicroFrance® (10381780092896)

GUDID

Device Identifier (DI) Information

Brand Name: MicroFrance®
Version or Model: CEV397BG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CEV397BG
Company Name: INTEGRA MICROFRANCE

Primary DI Number: 10381780092896
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276593071 *Terms of Use

Device Description: MicroFrance® Gayet bipolar forceps, fenestrated jaws, 3.5 mm diameter, 330 mm length, graduated tube 100 mm, ergonomic handle

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?
32684	Endoscopic electrosurgical handpiece/electrode, bipolar, reusable	An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Store in a clean, dry area; Do Not Use if Package is Damaged

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 3.5 Millimeter
Length: 330 Millimeter
Device Size Text, specify: 100 mm (Tube)

Device Record Status

Public Device Record Key: 75e62205-73d7-4691-afb3-58607f076e82
Public Version Date: October 28, 2024
Public Version Number: 6
DI Record Publish Date: September 20, 2016