COX

GUDID 18052286424192

Coaxial Introducer Needle for biopsies on soft tissue, for Medcut 18G X 160 mm

MEDAX SRL UNIPERSONALE

Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use
Primary Device ID18052286424192
NIH Device Record Key43f05e23-eebf-44fa-9d58-b79b4fe6baa8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOX
Version Model NumberCM18160-10
Company DUNS440211428
Company NameMEDAX SRL UNIPERSONALE
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108052286424195 [Primary]
GS108052286424195 [Primary]
GS108052286424195 [Primary]
GS108052286424195 [Primary]
GS118052286424192 [Package]
Contains: 08052286424195
Package: [10 Units]
In Commercial Distribution
GS118052286424192 [Package]
Contains: 08052286424195
Package: [10 Units]
In Commercial Distribution
GS118052286424192 [Package]
Contains: 08052286424195
Package: [10 Units]
In Commercial Distribution
GS118052286424192 [Package]
Contains: 08052286424195
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy
KNWInstrument, Biopsy
KNWInstrument, Biopsy
KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [COX]

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18052286423676Coaxial Introducer Needle for biopsies on soft tissue, for Medone 20G X 200 mm
18052286423669Coaxial Introducer Needle for biopsies on soft tissue 20G X 160 mm
18052286423607Coaxial Introducer Needle for biopsies on soft tissue, for Medone 18G X 100 mm
18052286423492Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 14G X 200 mm
18052286423485Coaxial Introducer Needle for biopsies on soft tissue, for Medone ultra 14G X 160 mm
18052286423478Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 14G X 100 mm
18052286423461Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 12G X 200 mm
18052286423454Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 12G X 160 mm
18052286423447Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 12G X 100 mm
18052286423584Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 20G X 200 mm
18052286423577Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 20G X 160 mm
18052286423560Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 20G X 100 mm
18052286423553Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 18G X 200 mm
18052286423546Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 18G x 160 mm
18052286423539Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 18G X 100 mm
18052286423522Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 16G X 200 mm
18052286423515Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 16G x 160 mm
18052286423508Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 16G X 100 mm
18052286424222Coaxial Introducer Needle for biopsies on soft tissue, for Medcut 20G X 160 mm
18052286424215Coaxial Introducer Needle for biopsies on soft tissue, for Medcut 20G X 100 mm
18052286424208Coaxial Introducer Needle for biopsies on soft tissue, for Medcut 18G X 200 mm
18052286424192Coaxial Introducer Needle for biopsies on soft tissue, for Medcut 18G X 160 mm
18052286424185Coaxial Introducer Needle for biopsies on soft tissue, for Medcut 18G X 100 mm
18052286424178Coaxial Introducer Needle for biopsies on soft tissue, for Medcut 16G X 160 mm

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