AprioCore plus ACP16-185-10

GUDID 17350031350132

AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.

Apriomed AB

Side-notch biopsy gun handpiece/needle
Primary Device ID17350031350132
NIH Device Record Keyd9c6a1a2-cec9-43d6-b870-2cdc6e2129bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAprioCore plus
Version Model NumberACP16-185-10
Catalog NumberACP16-185-10
Company DUNS631734758
Company NameApriomed AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Phone+46184301440
Emailinfo@apriomed.com

Device Dimensions

Needle Gauge16 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS107350031350135 [Primary]
GS117350031350132 [Package]
Contains: 07350031350135
Package: Shelf box [5 Units]
In Commercial Distribution
GS127350031350139 [Package]
Package: Transportation box [12 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-31
Device Publish Date2020-03-23

On-Brand Devices [AprioCore plus]

17350031350163AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
17350031350156AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
17350031350149AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
17350031350132AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
17350031350125AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
17350031350118AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
17350031350101AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
17350031350095AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
17350031350088AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
17350031350071AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
17350031350064AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
17350031350057AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.

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