Steriking® LTSS4

GUDID 06438263663092

Single use sterilization packaging

WIPAK PACKAGING (CHANGSHU) CO., LTD.

Sterilization packaging, single-use

• Primary Device ID: 06438263663092
• NIH Device Record Key: 0e2eeccd-ba03-47b2-a9cd-65b309def873
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steriking®
• Version Model Number: LTSS4
• Catalog Number: LTSS4
• Company DUNS: 543001936
• Company Name: WIPAK PACKAGING (CHANGSHU) CO., LTD.
• 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	06438263660138 [Primary]
GS1	06438263663092 [Package]; Contains: 06438263660138; Package: [5 Units]; In Commercial Distribution
GS1	06438263663368 [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

[06438263663092]

Hydrogen Peroxide;Ethylene Oxide

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

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• 06438263660107: Single use sterilization packaging