Transfermoral Transcaval Liver Biopsy System TF-18C

GUDID 20886333227659

Transfermoral Transcaval Liver Biopsy System

ARGON MEDICAL DEVICES, INC.

End-cut biopsy gun handpiece/needle
Primary Device ID20886333227659
NIH Device Record Keyf43cfd9e-642a-42b5-a756-2a3c0d27550a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransfermoral Transcaval Liver Biopsy System
Version Model NumberTF-18C
Catalog NumberTF-18C
Company DUNS140727624
Company NameARGON MEDICAL DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 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
GS100886333227655 [Primary]
GS120886333227659 [Package]
Contains: 00886333227655
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-20
Device Publish Date2024-08-12

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