AccessGUDID - DEVICE: Integra® Jarit® (10381780190967)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: 400235
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400-235
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780190967
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® Wiener Antrum Rasp, 7-3/4", Medium, 4mm Wide, Trocar Tip

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?
42379	Frontal sinus file/rasp	A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to scrape, clean out, and enlarge the frontal sinus cavities during ear/nose/throat (ENT) surgery. It is available in two main designs: 1) a one-piece instrument that has circular cutting ridges at the tip of the curved distal working end and a handle at the proximal end; or 2) a tubular construction that allows for integrated suction (a tube from a suction system is connected to its proximal end) and a rasp (e.g., diamond coating) at the contoured working end. It is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAZ	RASP, FRONTAL-SINUS

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
Width: 4 Millimeter
Device Size Text, specify: 7-3/4"

Device Record Status

Public Device Record Key: 4a3429ff-2cf5-4d90-8a08-73cb9858a714
Public Version Date: April 25, 2023
Public Version Number: 6
DI Record Publish Date: April 02, 2018