AccessGUDID - DEVICE: METZENBAUM PREPARATION SCISSORS INSERT (B09929013010)

GUDID

Device Identifier (DI) Information

Brand Name: METZENBAUM PREPARATION SCISSORS INSERT
Version or Model: 2901-301
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B09929013010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: METZENBAUM PREPARATION SCISSORS STRAIGHT DOUBLE-ACTION 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 hand-held manual surgical instrument designed cut a variety of tissues during surgery (i.e., is not dedicated to a specific anatomy/clinical intended use); it may 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 high-grade stainless steel and is available in various designs and sizes; the blades may have different shapes. 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 hand-held manual surgical instrument designed cut a variety of tissues during surgery (i.e., is not dedicated to a specific anatomy/clinical intended use); it may 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 high-grade stainless steel and is available in various designs and sizes; the blades may have different shapes. 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

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Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

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
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Ø5mm TUBE SHAFT 360mm

Device Record Status

Public Device Record Key: 1dcde079-ec85-4bb3-8213-2b9d7aafdd7b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 19, 2016