1ml Tuberculin Suresafe Syringe - 1ml Tuberculin Suresafe Automatic Retractable - DMC MEDICAL LIMITED

Duns Number:989772017

Device Description: 1ml Tuberculin Suresafe Automatic Retractable Safety Syringe - 25G x 1" - Sterile

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More Product Details

Catalog Number

FD-SSFX01T-25-01

Brand Name

1ml Tuberculin Suresafe Syringe

Version/Model Number

1ml Tuberculin Syringe - 25G x 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"

-

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

dc591d91-7eea-4f7b-9c70-b829de8e3ab0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 11, 2016

Additional Identifiers

Package DI Number

05391530750264

Quantity per Package

21

Contains DI Package

05391530750257

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