AccessGUDID - DEVICE: Integra® MicroFrance® (10381780539087)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® MicroFrance®
Version or Model: CEV568
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CEV568
Company Name: INTEGRA MICROFRANCE

Primary DI Number: 10381780539087
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 276593071 *Terms of Use
Previous DI: 10381780094005

Device Description: Integra® MicroFrance® Sartori vascular clamp for CEV560 and CEV560-1

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?
62470	Surgical bulldog clamp, reusable	A manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of high-grade stainless steel. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HET	LAPAROSCOPE, GYNECOLOGIC (AND 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 15 mm

Device Record Status

Public Device Record Key: c065f50a-40e8-4e12-b0fe-902252035f4d
Public Version Date: October 28, 2024
Public Version Number: 2
DI Record Publish Date: May 29, 2024