AccessGUDID - DEVICE: Sinton Medical Products (06938327900083)

GUDID

Device Identifier (DI) Information

Brand Name: Sinton Medical Products
Version or Model: 100114 - P
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HS-TCD200 Plus
Company Name: Shenzhen Boon Medical Supply Co., Ltd.

Primary DI Number: 06938327900083
Issuing Agency: GS1
Commercial Distribution End Date: April 27, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 529174252 *Terms of Use

Device Description: 2-200ml Syringes 2-Large Spikes & 2- fill straws 1-72" Y Coiled Tubing with Dual Check Valves

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?
15286	Angiographic syringe	A sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXT	Injector And Syringe, Angiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151960	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: 18ab5de6-2c6c-43bf-9854-629d84759bff
Public Version Date: April 28, 2020
Public Version Number: 7
DI Record Publish Date: November 11, 2016