886812

GUDID 50724995003055

The Vis-U-All Low Temperature Self Seal Pouch is used in the V-PRO Low Temperature Sterilization Systems and STERRAD NX, 100S and 100NX sterilizers.

STERIS CORPORATION

Sterilization packaging, single-use

• Primary Device ID: 50724995003055
• NIH Device Record Key: d73b5839-501f-4f0f-bcb5-1e62273bf882
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 886812
• Catalog Number: 886812
• 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
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Device Dimensions

• Length: 12 Inch
• Width: 8 Inch
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• Length: 12 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995003050 [Unit of Use]
GS1	10724995003057 [Primary]
GS1	50724995003055 [Package]; Contains: 10724995003057; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070765

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: 6
• Public Version Date: 2020-04-01
• Device Publish Date: 2017-01-17

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• 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.
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