885422

GUDID 50724995003178

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.

STERIS CORPORATION

Sterilization packaging, single-use
Primary Device ID50724995003178
NIH Device Record Keye344b176-9170-4e68-ada9-f5d1e278a318
Commercial Distribution StatusIn Commercial Distribution
Version Model Number885422
Catalog Number885422
Company DUNS961394798
Company NameSTERIS CORPORATION
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)548-4873
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Device Dimensions

Length22 Inch
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Device Identifiers

Device Issuing AgencyDevice ID
GS100724995003173 [Unit of Use]
GS110724995003170 [Primary]
GS150724995003178 [Package]
Contains: 10724995003170
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRGWrap, sterilization

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-04-01
Device Publish Date2017-01-17

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