AccessGUDID - DEVICE: Integra® Jarit® (10381780461203)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: 835100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 835-100
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780461203
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Explorer 5, Double-Ended, Octagonal Handle

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?
35812	Dental surgical probe, reusable	A slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKB	EXPLORER, OPERATIVE

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
No Device Sizes

Device Record Status

Public Device Record Key: fad3ebb7-06be-4016-9a1e-54ad4e1f1267
Public Version Date: January 20, 2023
Public Version Number: 5
DI Record Publish Date: March 22, 2018