ClosureFast Tumescent Infiltration Kit TIK-01

GUDID 20886333227574

ClosureFast™ Tumescent Infiltration Kit

ARGON MEDICAL DEVICES, INC.

General surgical procedure kit, non-medicated, reusable
Primary Device ID20886333227574
NIH Device Record Key918fba62-a096-48c3-bf94-dab1c737bfa3
Commercial Distribution StatusIn Commercial Distribution
Brand NameClosureFast Tumescent Infiltration Kit
Version Model NumberTIK-01
Catalog NumberTIK-01
Company DUNS140727624
Company NameARGON MEDICAL DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100886333227570 [Primary]
GS120886333227574 [Package]
Contains: 00886333227570
Package: Box [50 Units]
In Commercial Distribution

FDA Product Code

OEQAngiography/Angioplasty Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-06
Device Publish Date2024-07-29

Devices Manufactured by ARGON MEDICAL DEVICES, INC.

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20886333227505 - ClosureFast Guidewire2024-08-06 ClosureFast™ Guidewire Double Ended, PTFE, Fixed Core 0.035" (0.89mm) x 45cm
20886333227512 - ClosureFast Introducer Sheath 2024-08-06 ClosureFast Introducer Sheath Set 7Fr/Ch (2.3mm) x 7cm
20886333227529 - ClosureFast Introducer Sheath 2024-08-06 ClosureFast™ Introducer Sheath Set 7Fr/Ch (2.3mm) x 11cm
20886333227550 - ClosureFast Micro Puncture 2024-08-06 ClosureFast™ Micro Puncture Kit 4Fr/Ch (1.3mm)
20886333227567 - ClosureFast Micro Puncture2024-08-06 ClosureFast™ Micro Puncture Kit 5Fr/Ch (1.7mm)
20886333227574 - ClosureFast Tumescent Infiltration Kit2024-08-06ClosureFast™ Tumescent Infiltration Kit
20886333227574 - ClosureFast Tumescent Infiltration Kit2024-08-06 ClosureFast™ Tumescent Infiltration Kit

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