AccessGUDID - DEVICE: Coned Heparin Needles (B033KS400170)

GUDID

Device Identifier (DI) Information

Brand Name: Coned Heparin Needles
Version or Model: KS-4001-7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KS-4001-7
Company Name: Kapp Surgical Instrument Co.

Primary DI Number: B033KS400170
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004171112 *Terms of Use

Device Description: Coned Heparin Needles – Size 01 - 7in

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?
64113	Vascular irrigation cannula, peripheral	A sterile, rigid tube designed to be surgically inserted, temporarily, into a peripheral blood vessel to function as a channel for the transport of irrigation fluid (e.g., saline, heparin solution) during open vascular surgery. It is typically made of metal with a shaped/bulbous tip (e.g., cone-, olive-shaped) and may be intended to be bent into shape; as it is a rigid device it is not intended to be advanced more than a minimal distance within the lumen of the blood vessel. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEA	Cannula, Surgical, General & Plastic Surgery

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: f1a21d1c-1bcc-492b-b01d-56a39a32cbbb
Public Version Date: June 22, 2023
Public Version Number: 1
DI Record Publish Date: June 14, 2023