Kitazato OPU Reduced Needle, Type3-v5 340001

GUDID 14580303269302

KITAZATO CORPORATION

Soft-tissue biopsy procedure kit, non-medicated
Primary Device ID14580303269302
NIH Device Record Key52db68a6-a660-4dee-96e5-d760ef85119a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKitazato OPU Reduced Needle, Type3-v5
Version Model Number340001 Type3-v5
Catalog Number340001
Company DUNS711091157
Company NameKITAZATO CORPORATION
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 Numbertrue
Manufacturing Datefalse
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
GS104580303269305 [Primary]
GS114580303269302 [Package]
Contains: 04580303269305
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQENEEDLE, ASSISTED REPRODUCTION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-01-08
Device Publish Date2018-05-30

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