AccessGUDID - DEVICE: Integra® Jarit® (10381780198888)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: 400298
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400-298
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780198888
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® Faulkner Antrum Curette, 8-1/2", Double-Ended, 7.2mm And 10.4mm Rings, Sharp

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?
33450	Salpingeal curette	A slender, hand-held, surgical instrument that is used to clear blockages of the Eustachian tube during an ear/nose/throat (ENT) procedure. It is typically made of high-grade stainless steel and can be either rigid or malleable (bendable) and has a small, half-rounded, head terminating in a sharp scraping edge at its widest diameter at the curved distal end of a long shaft which has a handle at the proximal end. The scraping tip is available in various shapes and sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAP	CURETTE, NASAL

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: 7.2mm and 10.4mm Rings
Device Size Text, specify: 8-1/2"

Device Record Status

Public Device Record Key: e4693030-a7e0-4814-b4cf-34fbb6212a2d
Public Version Date: April 19, 2023
Public Version Number: 6
DI Record Publish Date: October 31, 2017