Tearduct Catheter TD100

GUDID 10887714012140

Catheter intended for dacryocystoplasty.

NUMED, INC.

Lacrimal dilator, single-use

• Primary Device ID: 10887714012140
• NIH Device Record Key: 5e282e33-c12a-4bf1-9cb2-5f21031d6d07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tearduct Catheter
• Version Model Number: 352
• Catalog Number: TD100
• Company DUNS: 114186877
• Company Name: NUMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887714012140 [Primary]

FDA Product Code

• HNW: Dilator, Lachrymal

Sterilization

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

[10887714012140]

Ethylene Oxide

[10887714012140]

Ethylene Oxide

[10887714012140]

Ethylene Oxide

[10887714012140]

Ethylene Oxide

[10887714012140]

Ethylene Oxide

[10887714012140]

Ethylene Oxide

[10887714012140]

Ethylene Oxide

[10887714012140]

Ethylene Oxide

[10887714012140]

Ethylene Oxide

[10887714012140]

Ethylene Oxide

[10887714012140]

Ethylene Oxide

[10887714012140]

Ethylene Oxide

[10887714012140]

Ethylene Oxide

[10887714012140]

Ethylene Oxide

[10887714012140]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-20

Devices Manufactured by NUMED, INC.

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• 10887714024563 - REBOA Catheter: 2019-03-21 A coaxial catheter recommended for temporary occlusion of the aorta.
• 10887714024570 - REBOA Catheter: 2019-03-21 A coaxial catheter recommended for temporary occlusion of the aorta.
• 10887714024587 - REBOA Catheter: 2019-03-21 A coaxial catheter recommended for temporary occlusion of the aorta.
• 10887714024594 - REBOA Catheter: 2019-03-21 A coaxial catheter recommended for temporary occlusion of the aorta.
• 10887714024600 - REBOA Catheter: 2019-03-21 A coaxial catheter recommended for temporary occlusion of the aorta.
• 10887714024617 - REBOA Catheter: 2019-03-21 A coaxial catheter recommended for temporary occlusion of the aorta.