TLS 6630

GUDID 37613252088432

QUINTUBE¿ Monitor Pack (5 tubes/pk, 24 p

Stryker Leibinger GmbH & Co. KG

Closed-wound drainage kit

• Primary Device ID: 37613252088432
• NIH Device Record Key: 0b1cf088-dc18-4f3d-9084-c14003d4f84b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TLS
• Version Model Number: 6630
• Catalog Number: 6630
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 24
• DM Exempt: true
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252088431 [Unit of Use]
GS1	37613252088432 [Package]; Contains: 57613252088436; Package: pack [5 Units]; In Commercial Distribution
GS1	57613252088436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K833586

FDA Product Code

• GCY: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-24

On-Brand Devices [TLS]

• 37613252088432: QUINTUBE¿ Monitor Pack (5 tubes/pk, 24 p
• 37613252088470: 10 French Drain System, Sterile
• 37613252088449: 7 French Drain System, Sterile
• 37613252083574: 4mm Flat Drain with Side Holes, Sterile