NA - The Vis-U-All Low Temperature Heat Seal Pouch is - STERIS CORPORATION

Duns Number:961394798

Device Description: The Vis-U-All Low Temperature Heat Seal Pouch is used in the V-PRO Low Temperature Sterili The Vis-U-All Low Temperature Heat Seal Pouch is used in the V-PRO Low Temperature Sterilization Systems and STERRAD NX, 100S and 100NX sterilizers.

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More Product Details

Catalog Number

885412

Brand Name

NA

Version/Model Number

885412

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FRG

Product Code Name

Wrap, sterilization

Device Record Status

Public Device Record Key

804ad59c-b1d6-4653-bf3f-edb4e5763901

Public Version Date

November 03, 2020

Public Version Number

7

DI Record Publish Date

January 17, 2017

Additional Identifiers

Package DI Number

50724995003116

Quantity per Package

10

Contains DI Package

10724995003118

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"STERIS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1528
2 A medical device with a moderate to high risk that requires special controls. 1557