SourceMark - SOURCEMARK, LLC.

Duns Number:121225812

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More Product Details

Catalog Number

-

Brand Name

SourceMark

Version/Model Number

SMBLADEUF

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

-

Product Code Details

Product Code

LWK

Product Code Name

Razor, Surgical

Device Record Status

Public Device Record Key

a31180a6-8ab5-48f3-9854-674985530af9

Public Version Date

July 29, 2020

Public Version Number

1

DI Record Publish Date

July 21, 2020

Additional Identifiers

Package DI Number

10813799006743

Quantity per Package

50

Contains DI Package

00813799006739

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SOURCEMARK, LLC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 71