GBUK - Sterile Syringe 10ML Luer Slip without needle - Jiangsu Micsafe Medical Tehcnology Co.,LTD.

Duns Number:554400604

Device Description: Sterile Syringe 10ML Luer Slip without needle

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More Product Details

Catalog Number

-

Brand Name

GBUK

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

e1a6a52b-ed89-4a08-bb05-c1b6f238c848

Public Version Date

May 28, 2021

Public Version Number

1

DI Record Publish Date

May 20, 2021

Additional Identifiers

Package DI Number

16971911299214

Quantity per Package

100

Contains DI Package

06971911299217

Package Discontinue Date

May 20, 2021

Package Status

Not in Commercial Distribution

Package Type

box

"JIANGSU MICSAFE MEDICAL TEHCNOLOGY CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5