AccessGUDID - DEVICE: Integra® (10381780082682)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: 3723005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3723005
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780082682
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Fisch Crura Scissors, Very Delicate, Left

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?
33414	Ear scissors, reusable	A long, thin, hand-held manual surgical instrument designed to cut tissue during ear surgery; it is not intended for insertion through an endoscope. Sometimes referred to as alligator scissors, it typically has a slender body (to allow for restricted access) and small shearing blades which are hinged at the distal (working) end. It is made of metal and available in various sizes/lengths; the blades may have carbide inserts along the cutting edges. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JZB	SCISSORS, EAR

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
Length: 2 Millimeter
Device Size Text, specify: 3" Shaft

Device Record Status

Public Device Record Key: 672f42a3-bf47-404e-a20f-15b948b1718b
Public Version Date: April 17, 2023
Public Version Number: 5
DI Record Publish Date: October 24, 2018