AccessGUDID - DEVICE: NA (07613327052657)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0250080263
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0250-080-263
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327052657
Issuing Agency: GS1
Commercial Distribution End Date: January 11, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: Insert, Straight Metzenbaum Scissors (Long Jaws)

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
General-purpose surgical scissors, reusable	A non-dedicated, hand-held manual surgical instrument designed to cut a variety of tissues during open surgery; it is not dedicated to surgery at a specific anatomy/body orifice nor does it have a single clinical intended use. It might in addition be intended for cutting sutures or other materials associated with surgery. It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.

GMDN Preferred Term Name

GMDN Definition

General-purpose surgical scissors, reusable

A non-dedicated, hand-held manual surgical instrument designed to cut a variety of tissues during open surgery; it is not dedicated to surgery at a specific anatomy/body orifice nor does it have a single clinical intended use. It might in addition be intended for cutting sutures or other materials associated with surgery. It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.

FDA Product Code

[?]

Product Code	Product Code Name
OCZ	Endoscopic grasping/cutting instrument, non-powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 33.0 Centimeter
Outer Diameter: 5.0 Millimeter

Device Record Status

Public Device Record Key: f18b29c7-d912-4d2b-bae0-2b87cb807215
Public Version Date: January 11, 2019
Public Version Number: 5
DI Record Publish Date: September 23, 2016