AccessGUDID - DEVICE: Integra® Jarit® (10381780407713)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: X33011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X33011
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780407713
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® Lewis Tonsil Screw, 8", Two Sharp Points, Standard Small Size

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?
14070	Tonsillectome	A hand-held manual surgical instrument designed to remove tonsils during a toncillectomy. It can be designed as either a flexible loop for grasping and holding the tonsil or a metal frame which holds and guides a sliding knife blade (a guillotine). The loop type holds the tonsil so it may be surgically cut with a knife. The frame type has a variety of designs of manual cranks that operate the sliding knife blade which cuts off the tonsil. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KBX	SCREW, TONSIL

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: 42c4dd25-0d6c-4b90-a6a8-72200f77dda7
Public Version Date: April 21, 2023
Public Version Number: 3
DI Record Publish Date: August 16, 2018