Syringes Safety - SYR U100 .5cc 29x.5 - GERI-GENTLE CORPORATION

Duns Number:361663839

Device Description: SYR U100 .5cc 29x.5

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More Product Details

Catalog Number

-

Brand Name

Syringes Safety

Version/Model Number

11467

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

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

-

Product Code Details

Product Code

MEG

Product Code Name

Syringe, Antistick

Device Record Status

Public Device Record Key

8b054c29-dc96-4aa1-8269-2a114bce2893

Public Version Date

June 10, 2019

Public Version Number

1

DI Record Publish Date

June 01, 2019

Additional Identifiers

Package DI Number

20369771000904

Quantity per Package

5

Contains DI Package

10369771000907

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner

"GERI-GENTLE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 23