AccessGUDID - DEVICE: Integra® Jarit® (10381780386476)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: 285425
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 285-425
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780386476
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® D'Errico Nerve Root Retractor, 8-3/4", 7.8mm Wide, Bayonet

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?
46768	Nerve/vessel retractor	A hand-held, non-self-retaining surgical instrument intended to be used for retracting a nerve, tendon, or blood vessel to separate it from the surrounding tissue primarily to allow access to other tissues during a surgical intervention. It is a shaft-like metallic instrument with a blunt bulbous or rounded hook-like retraction tip at the distal end, and a handle at the proximal end. It is available in a variety of designs such as, curved, right-angled, or 45 degree angled. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	RETRACTOR

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: 1/4" Width
Width: 7.8 Millimeter
Device Size Text, specify: 8-3/4"

Device Record Status

Public Device Record Key: 1c580612-77c4-46bb-aaa5-d64a04fd73c5
Public Version Date: May 16, 2023
Public Version Number: 7
DI Record Publish Date: September 29, 2017