Tearduct Catheter TD100

GUDID 10887714012140

Catheter intended for dacryocystoplasty.

NUMED, INC.

Lacrimal dilator, single-use
Primary Device ID10887714012140
NIH Device Record Key5e282e33-c12a-4bf1-9cb2-5f21031d6d07
Commercial Distribution StatusIn Commercial Distribution
Brand NameTearduct Catheter
Version Model Number352
Catalog NumberTD100
Company DUNS114186877
Company NameNUMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110887714012140 [Primary]

FDA Product Code

HNWDilator, Lachrymal

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-20

Devices Manufactured by NUMED, INC.

10887714024549 - REBOA Catheter2019-03-21 A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024556 - REBOA Catheter2019-03-21 A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024563 - REBOA Catheter2019-03-21 A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024570 - REBOA Catheter2019-03-21 A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024587 - REBOA Catheter2019-03-21 A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024594 - REBOA Catheter2019-03-21 A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024600 - REBOA Catheter2019-03-21 A coaxial catheter recommended for temporary occlusion of the aorta.
10887714024617 - REBOA Catheter2019-03-21 A coaxial catheter recommended for temporary occlusion of the aorta.

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