Syringe 3ml - Syringe 3ml - GERI-GENTLE CORPORATION

Duns Number:361663839

Device Description: Syringe 3ml

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More Product Details

Catalog Number

-

Brand Name

Syringe 3ml

Version/Model Number

11-300

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

K113091,K113091

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

166a464e-0076-4a7b-86dd-7f87ba7dc01f

Public Version Date

January 11, 2021

Public Version Number

1

DI Record Publish Date

January 01, 2021

Additional Identifiers

Package DI Number

00369771001792

Quantity per Package

100

Contains DI Package

00369771001785

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