AccessGUDID - DEVICE: WESTCOTT Scissors (04042796016595)

GUDID

Device Identifier (DI) Information

Brand Name: WESTCOTT Scissors
Version or Model: 09.102.11
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Dimeda Instrumente GmbH

Primary DI Number: 04042796016595
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 317327724 *Terms of Use

Device Description: WESTCOTT Ophthalmic Tendons Scissors sh/sh.

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):	No
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?
13488	Intraocular scissors, conventional-hinge, reusable	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue of the anterior segment (e.g., iris). It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (i.e., not a probe-like device). It is typically metallic, may have ring handles or spring handles, and is available with various blade designs and sizes. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNF	Scissors, Ophthalmic

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: 11 Centimeter

Device Record Status

Public Device Record Key: f91ca8da-d788-495b-9f15-d54b83960460
Public Version Date: July 14, 2023
Public Version Number: 3
DI Record Publish Date: May 15, 2017