Batrik Viscoelastic Poly/ Full Size - Blue Cloud Viscoelastic Poly/ Full Size - Batrik Medical Manufacturing Inc

Duns Number:243880700

Device Description: Blue Cloud Viscoelastic Poly/ Full Size

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More Product Details

Catalog Number

81-300A

Brand Name

Batrik Viscoelastic Poly/ Full Size

Version/Model Number

81-300A

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

-

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

CCX

Product Code Name

Support, Patient Position

Device Record Status

Public Device Record Key

02bd13d7-035b-47ab-b896-295f036fc66e

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 25, 2020

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