SPiN Perc Localization Needle 19ga x 105mm, 1cm marking zone INS-5610

GUDID 00815686021139

VERAN MEDICAL TECHNOLOGIES INC.

Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Soft-tissue biopsy needle, single-use Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system
Primary Device ID00815686021139
NIH Device Record Keyb83f4de2-a9f5-41b0-b907-4ac9392c38de
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPiN Perc Localization Needle 19ga x 105mm, 1cm marking zone
Version Model NumberINS-5610
Catalog NumberINS-5610
Company DUNS181714804
Company NameVERAN MEDICAL TECHNOLOGIES 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100815686021139 [Primary]
GS110815686021136 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

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 Date2018-01-25

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