Securegard - Securegard 3 ml 21Gx1" syringe - SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag

Duns Number:401217526

Device Description: Securegard 3 ml 21Gx1" syringe

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More Product Details

Catalog Number

5348P

Brand Name

Securegard

Version/Model Number

1.0

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K993609,K993609,K993609

Product Code Details

Product Code

MEG

Product Code Name

Syringe, Antistick

Device Record Status

Public Device Record Key

7e58093f-6475-434f-9c3e-476c0d156d92

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

5999039512392

Quantity per Package

10

Contains DI Package

5999039512385

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"SAFEGARD MEDICAL /HUNGARY/ GYOGYASZATI ESZKOZGYARTO ES FORGALMAZO KORLATOLT FELELOSSEGU TARSASAG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22