884816

GUDID 50724995152609

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

STERIS CORPORATION

Sterilization packaging, single-use

Primary Device ID	50724995152609
NIH Device Record Key	c5294cc1-2629-4362-8af4-90098e193c83
Commercial Distribution Status	In Commercial Distribution
Version Model Number	884816
Catalog Number	884816
Company DUNS	961394798
Company Name	STERIS CORPORATION
Device Count	200
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Customer Support Contacts

Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx
Phone	+1(800)548-4873
Email	xx@xx.xx

Device Dimensions

Width	8 Inch
Length	16 Inch
Width	8 Inch
Length	16 Inch
Width	8 Inch
Length	16 Inch
Width	8 Inch
Length	16 Inch
Width	8 Inch
Length	16 Inch
Width	8 Inch
Length	16 Inch
Width	8 Inch
Length	16 Inch
Width	8 Inch
Length	16 Inch
Width	8 Inch
Length	16 Inch
Width	8 Inch
Length	16 Inch
Width	8 Inch
Length	16 Inch
Width	8 Inch
Length	16 Inch
Width	8 Inch
Length	16 Inch
Width	8 Inch
Length	16 Inch
Width	8 Inch
Length	16 Inch
Width	8 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995152604 [Unit of Use]
GS1	10724995152601 [Primary]
GS1	50724995152609 [Package] Contains: 10724995152601 Package: Case [4 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153540

FDA Product Code

FRG	Wrap, sterilization

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-11-08
Device Publish Date	2017-01-27

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