AccessGUDID - DEVICE: Integra® Jarit® (10381780214076)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: P3575
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780214076
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Jost Cartilage Crusher

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?
18129	Manual bone mill	A manually-operated, non-patient-contact device intended to be used to grind bone into a slurry or a powder for use as a bone matrix for bone regeneration or bone grafting. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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: 3a396601-49bf-46d6-9116-2eac9a24e8b4
Public Version Date: March 19, 2024
Public Version Number: 5
DI Record Publish Date: September 29, 2017