Vermed - SHRPCHEMO 3GAL/12L USA YELLOW, ROUND - GRAPHIC CONTROLS ACQUISITION CORP

Duns Number:002111896

Device Description: SHRPCHEMO 3GAL/12L USA YELLOW, ROUND

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More Product Details

Catalog Number

32028567

Brand Name

Vermed

Version/Model Number

SHRPCHEMO 3GAL/12L USA YELLOW, ROUND

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K071517,K071517,K071517

Product Code Details

Product Code

MMK

Product Code Name

Container, Sharps

Device Record Status

Public Device Record Key

cf6705b0-1442-4122-8eea-29ddb8f3722f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 01, 2017

Additional Identifiers

Package DI Number

70009336008826

Quantity per Package

8

Contains DI Package

50009336008822

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"GRAPHIC CONTROLS ACQUISITION CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 161
2 A medical device with a moderate to high risk that requires special controls. 269
3 A medical device with high risk that requires premarket approval 1