STENTube

GUDID 10634624715520

STENTube intubation set

QUEST MEDICAL INC

Lacrimal tube

• Primary Device ID: 10634624715520
• NIH Device Record Key: 2e72c333-6582-44d1-8910-356a56976d0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STENTube
• Version Model Number: LIS052
• Company DUNS: 041810693
• Company Name: QUEST MEDICAL INC
• Device Count: 1
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10634624715520 [Primary]
GS1	20634624715527 [Package]; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113118

FDA Product Code

• OKS: Lacrimal Stents And Intubation Sets

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-05-18

Devices Manufactured by QUEST MEDICAL INC

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• 20634624101252 - Q2 IV Administration Set: 2022-12-14
• 20634624101306 - Q2 IV Administration Set: 2022-12-14
• 20634624601257 - Q2 IV Administration Set: 2022-12-14
• 20634624921096 - High-Flow 4-Way Stopcock: 2022-12-14
• 20634624921102 - High-Flow 4-Way Stopcock: 2022-12-14