Batrik SKINS- Marker - Sterile - Multi-Tip fine marker (Volume Packaging), Sterile - Batrik Medical Manufacturing Inc

Duns Number:243880700

Device Description: Multi-Tip fine marker (Volume Packaging), Sterile

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More Product Details

Catalog Number

S-30015

Brand Name

Batrik SKINS- Marker - Sterile

Version/Model Number

S-30015

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

-

Product Code Details

Product Code

FZZ

Product Code Name

Marker, Skin

Device Record Status

Public Device Record Key

76645a35-abb4-4365-aeca-9d4b6e3e2014

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BATRIK MEDICAL MANUFACTURING INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 748
2 A medical device with a moderate to high risk that requires special controls. 20