AccessGUDID - DEVICE: Integra® Jarit® (10381780406570)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: X304441
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X304441
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780406570
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® Walther Female Dilator-Catheter, 5-5/8", 30 French

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?
13643	Urethral sound, reusable	A hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FBX	SOUND, URETHRAL, METAL OR PLASTIC

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
Special Storage Condition, Specify: No

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5-5/8"
Catheter Gauge: 30 French

Device Record Status

Public Device Record Key: ad9dcc41-cb8e-45d0-bf80-425c21d2ba6e
Public Version Date: November 13, 2024
Public Version Number: 6
DI Record Publish Date: May 16, 2017