ACN™ Biopsy Needle ACN1816MF

GUDID 20886333007299

ACN™ Biopsy Needle 18ga x 16cm

ARGON MEDICAL DEVICES, INC.

Soft-tissue biopsy needle, single-use
Primary Device ID20886333007299
NIH Device Record Key0dcd5f08-b3d0-4fc4-be9a-abd0e2cc352a
Commercial Distribution StatusIn Commercial Distribution
Brand NameACN™ Biopsy Needle
Version Model NumberACN1816MF
Catalog NumberACN1816MF
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
GS100886333007295 [Primary]
GS120886333007299 [Package]
Contains: 00886333007295
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 Date2016-09-01

On-Brand Devices [ACN™ Biopsy Needle]

20886333007398ACN™ Biopsy Needle 16ga x 16cm
20886333007381ACN™ Biopsy Needle 14ga x 10cm
20886333007374ACN™ Biopsy Needle 18ga x 25cm
20886333007367ACN™ Biopsy Needle 18ga x 20cm
20886333007350ACN™ Biopsy Needle 18ga x 10cm
20886333007343ACN™ Biopsy Needle 16ga x 20cm
20886333007336ACN™ Biopsy Needle 20ga x 10cm
20886333007329ACN™ Biopsy Needle 16ga x 10cm
20886333007312ACN™ Biopsy Needle 20ga x 16cm
20886333007305ACN™ Biopsy Needle 14ga x 20cm
20886333007299ACN™ Biopsy Needle 18ga x 16cm
20886333007282ACN™ Biopsy Needle 14ga x 12cm
20886333007275ACN™ Biopsy Needle 14ga x 16cm
20886333007268ACN™ Biopsy Needle 16ga x 25cm
20886333007251ACN™ Biopsy Needle 20ga x 20cm
20886333007237ACN™ Biopsy Needle 18ga x 30cm

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