AccessGUDID - DEVICE: Integra® Jarit® (10381780458333)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: 385430
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 385-430
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780458333
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® Derlacki Ossicle Holding Clamp, 4-7/8", Vertical and Horizontal Groove

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?
35802	Otologic clamp	A hand-held manual surgical instrument designed to grasp internal ear structures (e.g., a bone of the ossicles) during an ear/nose/throat (ENT) procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel. It is available in various sizes and blade designs that may utilize carbide inserts. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JYF	CLAMP, OSSICLE HOLDING

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: 4-7/8"

Device Record Status

Public Device Record Key: 5b5c46fa-e1d9-4166-b273-ec888d79a78b
Public Version Date: April 19, 2023
Public Version Number: 5
DI Record Publish Date: March 02, 2018