AccessGUDID - DEVICE: Integra® Jarit® (10381780189152)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: 285385
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 285-385
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780189152
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® Cushing Staphylorraphy Elevator, 8", Grooved Handle, 6.5mm Wide

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?
11507	Neurosurgical bone flap elevator	A hand-held, manually-operated surgical instrument used to pry up, lift, and position a bone flap in a neurosurgical procedure upon the skull. Also known as a bone flap elevator it is typically a one-piece instrument that consists of a robust, long, round-nosed, dull blade at the distal working end and a handle at the proximal end. It is typically made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAO	INSTRUMENT, SURGICAL, NON-POWERED

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: 6.5 Millimeter
Length: 8 Inch

Device Record Status

Public Device Record Key: 47955fb4-2513-4e18-90c5-02aefa83d807
Public Version Date: November 19, 2024
Public Version Number: 6
DI Record Publish Date: October 31, 2017