0.5ml Suresafe Syringe - 0.5ml Suresafe Manual Retractable Syringe - 29G x - DMC MEDICAL LIMITED

Duns Number:989772017

Device Description: 0.5ml Suresafe Manual Retractable Syringe - 29G x 1/2"

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More Product Details

Catalog Number

FD-MSSFX005-29

Brand Name

0.5ml Suresafe Syringe

Version/Model Number

0.5ml Syringe 29G x 1/2"

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141349,K141349,K141349

Product Code Details

Product Code

MEG

Product Code Name

Syringe, Antistick

Device Record Status

Public Device Record Key

a41e2a7c-b4c6-4494-8bb4-904b6639227b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 06, 2017

Additional Identifiers

Package DI Number

05391530750714

Quantity per Package

30

Contains DI Package

05391530750707

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DMC MEDICAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 29