883122

GUDID 50724995152425

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 ID50724995152425
NIH Device Record Key39d58f36-64f4-4df5-92a8-b23606ebbe7b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number883122
Catalog Number883122
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
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

Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 Inch
Width18 Inch
Length22 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
GS100724995152420 [Unit of Use]
GS110724995152427 [Primary]
GS150724995152425 [Package]
Contains: 10724995152427
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

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00724995244910 - NA2025-05-13 Basic Headrest, Used with TAB830H
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00724995245016 - Clamp2025-05-13 Automatic Rotary Clamp
00724995245450 - HexaLux2025-05-13 The HexaLux Sterilizable Light Handle is used with the HexaLux Exam Light.

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