883610

GUDID 50724995152463

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 ID: 50724995152463
• NIH Device Record Key: 595d60eb-d5f5-4491-bb75-b0f924e143ef
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 883610
• Catalog Number: 883610
• 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: 6 Inch
• Length: 10 Inch
• Width: 6 Inch
• Length: 10 Inch
• Width: 6 Inch
• Length: 10 Inch
• Width: 6 Inch
• Length: 10 Inch
• Width: 6 Inch
• Length: 10 Inch
• Width: 6 Inch
• Length: 10 Inch
• Width: 6 Inch
• Length: 10 Inch
• Width: 6 Inch
• Length: 10 Inch
• Width: 6 Inch
• Length: 10 Inch
• Width: 6 Inch
• Length: 10 Inch
• Width: 6 Inch
• Length: 10 Inch
• Width: 6 Inch
• Length: 10 Inch
• Width: 6 Inch
• Length: 10 Inch
• Width: 6 Inch
• Length: 10 Inch
• Width: 6 Inch
• Length: 10 Inch
• Width: 6 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	00724995152468 [Unit of Use]
GS1	10724995152465 [Primary]
GS1	50724995152463 [Package]; Contains: 10724995152465; Package: Case [5 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

Devices Manufactured by STERIS CORPORATION

• 00724995221980 - NA: 2024-08-09 Orthopedic Extension and Abductor Bar Assembly is used with the 7000 Series Surgical Tables.
• 00724995221997 - NA: 2024-08-09 36-inch Imaging Extension without Pad, Velcro is used with the 7000 Series Surgical Tables.
• 00724995222000 - NA: 2024-08-09 36-inch Imaging Extension with 2-inch TLT Pad, Velcro is used with the 7000 Series Surgical Tables.
• 50724995211566 - Prolystica: 2024-08-08 Prolystica HP Enzymatic Manual Cleaner Fragrance Free is formulated to deliver superior performance during manual cleaning proce
• 00724995211585 - Prolystica: 2024-08-08 Prolystica HP Enzymatic Manual Cleaner Dye and Fragrance Free 2.5 Gallon is formulated to deliver superior performance during ma
• 00724995217266 - NA: 2024-08-07 The Replacement Pad Set is used with the PowerLift Plus Stirrups (pair) - Adult 500 pound is used with
• 00724995217273 - NA: 2024-08-07 The Replacement Pad Set is used with PowerLift Freedom Stirrups (pair) - Bariatric 800 pound is used with
• 00724995217242 - Secure-Release: 2024-08-02 The Secure-Release Clamp is designed to safely hold surgical accessories to the side rail and is compatible with STERIS 3000, 40