Steriking® LTS2550

GUDID 06438263614087

Single use sterilization packaging

Wipak Oy

Sterilization packaging, single-use

• Primary Device ID: 06438263614087
• NIH Device Record Key: dec81e6f-f412-47bf-b9ea-45d48557bc59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steriking®
• Version Model Number: LTS2550
• Catalog Number: LTS2550
• Company DUNS: 540103855
• Company Name: Wipak Oy
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438263614087 [Package]; Contains: 06438263614179; Package: [3 Units]; In Commercial Distribution
GS1	06438263614179 [Primary]
GS1	06438263660886 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973827

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[06438263614087]

Ethylene Oxide;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-26

On-Brand Devices [Steriking®]

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• 06438263644039: Single use sterilization packaging
• 06438263640864: Single use sterilization packaging
• 06438263640857: Single use sterilization packaging
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• 06438263630131: Single use sterilization packaging