AccessGUDID - DEVICE: Integra® (10381780086291)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: 3734123
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3734123
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780086291
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jako Micro Laryngeal Sickle Knife

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?
38105	Laryngeal knife	A hand-held manual surgical instrument designed to cut and dissect laryngeal tissue, including the vocal cords, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and available in various shapes (e.g., sickle, flap, straight) according to the procedure performed (e.g., excision of cysts, adhesions, webs). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JZY	KNIFE, LARYNGEAL

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: 11-1/2"

Device Record Status

Public Device Record Key: a7842fc3-3bb3-447f-aeed-222708a6ff75
Public Version Date: April 17, 2023
Public Version Number: 4
DI Record Publish Date: October 24, 2018