Franseen Needle FFN-1815

GUDID 20886333220254

Franseen Needle 18g x 15cm

ARGON MEDICAL DEVICES, INC.

Soft-tissue biopsy needle, single-use
Primary Device ID20886333220254
NIH Device Record Key35556446-075e-4b3f-be39-dbd72b289ba2
Commercial Distribution StatusIn Commercial Distribution
Brand NameFranseen Needle
Version Model NumberFFN-1815
Catalog NumberFFN-1815
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100886333220250 [Primary]
GS120886333220254 [Package]
Contains: 00886333220250
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [Franseen Needle]

20886333220292Franseen Needle 22g x 20cm
20886333220285Franseen Needle 22g x 15cm
20886333220278Franseen Needle 22g x 9cm
20886333220261Franseen Needle 20g x 9cm
20886333220254Franseen Needle 18g x 15cm

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