AccessGUDID - DEVICE: Praxis Medical CytoCore and CytoCore Luer Adapters (00860003935866)

GUDID

Device Identifier (DI) Information

Brand Name: Praxis Medical CytoCore and CytoCore Luer Adapters
Version or Model: C0025L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PRAXIS MEDICAL LLC

Primary DI Number: 00860003935866
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 939493362 *Terms of Use

Device Description: CytoCore device (DI 00860003935804) with extra luer adapters pouch (DI 00860003935835)

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:	Yes
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64880	Biopsy syringe holder, single-use	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materials and typically designed as a lightweight, hand-held frame in which the syringe is placed and its piston withdrawn using a sliding handle in the frame; a stopper may be included to prevent further aspiration at a predetermined point.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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNW	Instrument, Biopsy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200278	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: f3894c8f-3c20-438a-83fd-b287f5b2ded0
Public Version Date: June 15, 2022
Public Version Number: 1
DI Record Publish Date: June 07, 2022