AccessGUDID - DEVICE: Integra® Jarit® (10381780391340)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: 385606
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 385-606
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780391340
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® Morgan Tube Inserter, 4-1/8", 1.2mm Diameter

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?
33404	Tympanostomy tube inserter, reusable	A hand-held device intended to direct the insertion and placement of a tympanostomy tube (otherwise known as a myringotomy tube, grommet or an aural vent tube) through the external ear canal during ear/nose/throat (ENT) surgery. A tympanostomy tube is a device used to provide drainage from the middle ear through the tympanic membrane; the inserter is removed once the tube has been inserted. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JYM	INSERTER, MYRINGOTOMY TUBE

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: 08217ea4-6c76-4fe3-8f50-62e992734cea
Public Version Date: April 24, 2023
Public Version Number: 6
DI Record Publish Date: May 02, 2018