AccessGUDID - DEVICE: Integra® Jarit® (10381780198185)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: 380355
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 380-355
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780198185
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® Uebe Applicator, Twisted End

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?
33466	ENT powder applicator	An applicator designed to utilize blowing air, typically through the use of a hand-operated bulb, to administer powdered medication to the ear, nose, or oral cavity/throat during an ear/nose/throat (ENT) procedure or treatment. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCJ	APPLICATOR, ENT

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
Length: 7 Inch

Device Record Status

Public Device Record Key: 38ab616d-9b8e-44a7-b4d9-a860d4f52910
Public Version Date: December 19, 2023
Public Version Number: 6
DI Record Publish Date: October 31, 2017