AccessGUDID - DEVICE: Integra® Jarit® (10381780509134)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: X384131
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X384131
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780509134
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® Engel Cast Saw, 5-5/8"

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?
15774	Cast cutter blade	A surgical cutting device intended to be used with a cast removal tool (cast cutter) to provide the cutting edge for cutting through cast material so that this can be removed from the patient. It is formed as a thin, rounded, half moon-like, or circular blade with serrated teeth around its cutting edge. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGG	INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL

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: 5-7/8"

Device Record Status

Public Device Record Key: ca7ae05c-de30-4878-9c68-20ffff13927b
Public Version Date: April 19, 2023
Public Version Number: 4
DI Record Publish Date: October 23, 2018