883411

GUDID 50724995152432

The Vis-U-All High Temperature Heat Seal Sterilization Pouch is validated for use with ethylene oxide and steam sterilization.

STERIS CORPORATION

Sterilization packaging, single-use
Primary Device ID50724995152432
NIH Device Record Keyd79578f5-158a-461d-ae46-249bd117764f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number883411
Catalog Number883411
Company DUNS961394798
Company NameSTERIS CORPORATION
Device Count200
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
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx

Device Dimensions

Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch
Length11 Inch
Width5 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool and dry environment. Avoid direct sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS100724995152437 [Unit of Use]
GS110724995152434 [Primary]
GS150724995152432 [Package]
Contains: 10724995152434
Package: Case [5 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 Number5
Public Version Date2019-11-08
Device Publish Date2017-01-27

Devices Manufactured by STERIS CORPORATION

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50724995231069 - Prolystica2026-01-22 Prolystica Ultra Concentrate HP Enzymatic 3.5 Liter is designed for use in hospital washer-disinfector units and automated mecha
50724995231076 - Prolystica2026-01-22 Prolystica Ultra Concentrate HP Alkaline 3.5 Liter is designed for use in hospital washer-disinfector units and automated mecha
00724995243593 - ALYON2026-01-13 ALYON Camera Ready Lighthead is used with the ALYON Lighting System - DC
00724995204150 - PRO-LITE2025-12-24 The PRO-Lite Sterilization Tray Mat, 13-inch x 7.75-inch, is used in V-PRO Low Temperature Sterilization Systems and STERRAD NX,
00724995204167 - PRO-LITE2025-12-24 The PRO-Lite Sterilization Tray Mat, 19-inch x 7.75-inch, is used in V-PRO Low Temperature Sterilization Systems and STERRAD NX,
00724995204174 - PRO-LITE2025-12-24 The PRO-Lite Sterilization Tray Mat, 27-inch x 7.75-inch, is used in V-PRO Low Temperature Sterilization Systems and STERRAD NX,
50724995229554 - PRE-KLENZ2025-12-24 Pre-Klenz Enzymatic Soak Shield Kit is used to keep contaminated instruments moist during transportation for up to 72 hours

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