AccessGUDID - DEVICE: Integra® Jarit® (10381780379225)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: 140154
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 140-154
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780379225
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® Ferguson Gall Stone Scoop, 9-1/2", Double-Ended, Small

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?
13509	Gallstone scoop	A hand-held manual surgical instrument designed for the removal of gallstones. It is typically made of high-grade stainless steel and has a very long, thin, malleable (bendable) working end that terminates in a small spoon-like scoop. At the proximal end is a handle used by the surgeon to manipulate and operate the instrument during the removal procedure. It can have a variety of scoop designs. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FHL	SCOOP

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
Device Size Text, specify: 9-1/2"

Device Record Status

Public Device Record Key: 1165ace1-b74a-4d4a-aa5f-ccff9af9b565
Public Version Date: April 19, 2023
Public Version Number: 7
DI Record Publish Date: September 28, 2017