AccessGUDID - DEVICE: HEARTLINE MINI COOLEY SCISSORS (B0992800236L0)

GUDID

Device Identifier (DI) Information

Brand Name: HEARTLINE MINI COOLEY SCISSORS
Version or Model: 2800-236L
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B0992800236L0
Issuing Agency: HIBCC
Commercial Distribution End Date: June 22, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: HEARTLINE MINI COOLEY SCISSORS CURVED BLUNT BLADE SQUEEZE HANDLE

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

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

GMDN Preferred Term Name	GMDN Definition
Vascular scissors	A hand-held surgical instrument designed to cut a blood vessel (i.e., to cut over a blood vessel or cut longitudinally to split it open) during open vascular surgery; it is not intended for endoscopic use. It comprises two pivoted blades typically with a finger and thumb ring-handle and which cut with a shearing action. It is typically made of high-grade stainless steel and is available in various designs and sizes; the blades are often pointed to penetrate the vessel wall and may be straight, curved sideways, or acutely angled. 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

Vascular scissors

A hand-held surgical instrument designed to cut a blood vessel (i.e., to cut over a blood vessel or cut longitudinally to split it open) during open vascular surgery; it is not intended for endoscopic use. It comprises two pivoted blades typically with a finger and thumb ring-handle and which cut with a shearing action. It is typically made of high-grade stainless steel and is available in various designs and sizes; the blades are often pointed to penetrate the vessel wall and may be straight, curved sideways, or acutely angled. 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
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152400	000

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
Length: 29.4 Centimeter
Device Size Text, specify: 30° Blade
Device Size Text, specify: 3mm Diameter Shaft

Device Record Status

Public Device Record Key: 50ca8ba0-04df-4bac-a92e-8b573d6e3ef3
Public Version Date: July 06, 2018
Public Version Number: 7
DI Record Publish Date: August 19, 2016