Cyst Puncture Needle with Stylet

GUDID 17350025912384

Vitrolife Sweden AB

Endoscopic cyst-aspiration set
Primary Device ID17350025912384
NIH Device Record Keye7313e18-a13f-4c10-a5dc-1409f2a019a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCyst Puncture Needle with Stylet
Version Model Number14811
Company DUNS631805488
Company NameVitrolife Sweden AB
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 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
GS107350025912387 [Primary]
GS117350025912384 [Package]
Contains: 07350025912387
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNAInstrument, Manual, Specialized Obstetric-Gynecologic

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 Date2016-09-14

On-Brand Devices [Cyst Puncture Needle with Stylet]

1735002591563717812
1735002591562017811
1735002591560617809
1735002591558317806
1735002591557617805
1735002591555217803
1735002591239114812
1735002591238414811
1735002591236014809
0735002591233214806
0735002591232514805
0735002591230114803

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