PNEUVIEW XE 9660-XENS

GUDID 00852588007052

LAPAROSCOPIC SMOKE ELIMINATION DEVICE

LEXION MEDICAL, LLC

Laparoscopic plume filter
Primary Device ID00852588007052
NIH Device Record Key6a28dcec-891f-4f8b-9d84-dce295a8d921
Commercial Distribution StatusIn Commercial Distribution
Brand NamePNEUVIEW XE
Version Model Number9660-XENS
Catalog Number9660-XENS
Company DUNS848693730
Company NameLEXION MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852588007052 [Primary]

FDA Product Code

FCZTube, Smoke Removal, Endoscopic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00852588007052]

Ethylene Oxide


[00852588007052]

Ethylene Oxide


[00852588007052]

Ethylene Oxide


[00852588007052]

Ethylene Oxide


[00852588007052]

Ethylene Oxide


[00852588007052]

Ethylene Oxide


[00852588007052]

Ethylene Oxide


[00852588007052]

Ethylene Oxide


[00852588007052]

Ethylene Oxide


[00852588007052]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-02-15

On-Brand Devices [PNEUVIEW XE]

00852588007052LAPAROSCOPIC SMOKE ELIMINATION DEVICE
00852588007045LAPAROSCOPIC SMOKE ELIMINATION DEVICE

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