AccessGUDID - DEVICE: Coolject 1-3cc Syringe Holder Nozzle Accessory (00860006961534)

GUDID

Device Identifier (DI) Information

Brand Name: Coolject 1-3cc Syringe Holder Nozzle Accessory
Version or Model: VM01000-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Vapocoolshot, Inc

Primary DI Number: 00860006961534
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 032313444 *Terms of Use

Device Description: Coolject 1-3 cc Syringe Holder Nozzle Accessory, One per Box

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?
47674	Biopsy syringe holder, reusable	A hand-operated device designed to hold a biopsy syringe to facilitate precision aspiration of a tissue specimen through a biopsy needle. The holder is typically made of metal and plastic materials and typically designed as a lightweight, hand-held frame in which the syringe is placed and its piston withdrawn using a sliding handle in the frame; a stopper may be included to prevent further aspiration at a predetermined point. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZH	Introducer, Syringe Needle
MLY	Vapocoolant Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201248	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d3cc9a15-f444-4466-bf84-f5a2c3e59592
Public Version Date: November 19, 2024
Public Version Number: 2
DI Record Publish Date: January 27, 2023