884411

GUDID 50724995152562

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

STERIS CORPORATION

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• Primary Device ID: 50724995152562
• NIH Device Record Key: 77dda879-a4aa-4a70-8141-f8cd5444d5d1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 884411
• Catalog Number: 884411
• 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: 4 Inch
• Length: 11 Inch
• Width: 4 Inch
• Length: 11 Inch
• Width: 4 Inch
• Length: 11 Inch
• Width: 4 Inch
• Length: 11 Inch
• Width: 4 Inch
• Length: 11 Inch
• Width: 4 Inch
• Length: 11 Inch
• Width: 4 Inch
• Length: 11 Inch
• Width: 4 Inch
• Length: 11 Inch
• Width: 4 Inch
• Length: 11 Inch
• Width: 4 Inch
• Length: 11 Inch
• Width: 4 Inch
• Length: 11 Inch
• Width: 4 Inch
• Length: 11 Inch
• Width: 4 Inch
• Length: 11 Inch
• Width: 4 Inch
• Length: 11 Inch
• Width: 4 Inch
• Length: 11 Inch
• Width: 4 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	00724995152567 [Unit of Use]
GS1	10724995152564 [Primary]
GS1	50724995152562 [Package]; Contains: 10724995152564; 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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• 00724995225223 - NA: 2024-06-11 enspire 3000 Leak Test Adapter, ENLCSLTL1
• 00724995225230 - NA: 2024-06-11 enspire 3000 Leak Test Adapter, ENLCSLTP1
• 00724995225247 - NA: 2024-06-11 enspire 3000 Leak Test Adapter, ENLCSLTP2
• 00724995225254 - NA: 2024-06-11 enspire 3000 Leak Test Adapter, ENLCSLTR1
• 00724995225261 - NA: 2024-06-11 enspire 3000 MaxFlow Connector, ENLCS601
• 00724995225278 - NA: 2024-06-11 enspire 3000 MaxFlow Connector, ENLCS602