884116

GUDID 50724995152517

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: 50724995152517
• NIH Device Record Key: f02ecf25-e031-444d-9afe-79cff186e29c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 884116
• Catalog Number: 884116
• Company DUNS: 961394798
• Company Name: STERIS CORPORATION
• Device Count: 100
• 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: 16 Inch
• Length: 16 Inch
• Width: 16 Inch
• Length: 16 Inch
• Width: 16 Inch
• Length: 16 Inch
• Width: 16 Inch
• Length: 16 Inch
• Width: 16 Inch
• Length: 16 Inch
• Width: 16 Inch
• Length: 16 Inch
• Width: 16 Inch
• Length: 16 Inch
• Width: 16 Inch
• Length: 16 Inch
• Width: 16 Inch
• Length: 16 Inch
• Width: 16 Inch
• Length: 16 Inch
• Width: 16 Inch
• Length: 16 Inch
• Width: 16 Inch
• Length: 16 Inch
• Width: 16 Inch
• Length: 16 Inch
• Width: 16 Inch
• Length: 16 Inch
• Width: 16 Inch
• Length: 16 Inch
• Width: 16 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	00724995152512 [Unit of Use]
GS1	10724995152519 [Primary]
GS1	50724995152517 [Package]; Contains: 10724995152519; Package: Case [6 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

• 00724995222017 - NA: 2024-12-03 Foot Extension with Siderail Locks, Velcro without Pad is used with the 7000 Series Surgical Table.
• 00724995222024 - NA: 2024-12-03 Foot Extension with Siderail Locks, Velcro with 2-inch TLT Pad is used with the 7000 Series Surgical Tables.
• 00724995222048 - NA: 2024-12-03 Bariatric Foot Extension withSiderail Locks, Velcro with 2-inch TLT Pad is used with the 7000 Series Surgical Table.
• 00724995222260 - NA: 2024-12-03 2-inch TLT Pad, Velcro, Foot Extension, is used with the 7000 Series Surgical Tables.
• 00724995222277 - NA: 2024-12-03 3-inch TLT Pad, Velcro, Foot Extension, is used with the 7000 Series Surgical Tables.
• 00724995222284 - NA: 2024-12-03 4-inch TLT Pad, Velcro, Foot Extension, is used with the 7000 Series Surgical Tables.
• 00724995222291 - NA: 2024-12-03 2-inch TLT Pad, Velcro, Bariatric Foot Extension, is used with the 7000 Series Surgical Tables.
• 00724995222307 - NA: 2024-12-03 3-inch TLT Pad, Velcro, Bariatric Foot Extension, is used with the 7000 Series Surgical Tables.