Peelaway Introducer Sheath, 14Fr 1305-014

GUDID 00810004820746

Peelaway Introducer Sheath, 14 French, Dome Tipped

CLARUS MEDICAL, LLC

Endoscope sheath, single-use
Primary Device ID00810004820746
NIH Device Record Key6088df92-1052-4dfc-b7c4-9484b54c7d08
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeelaway Introducer Sheath, 14Fr
Version Model Number1305-014
Catalog Number1305-014
Company DUNS010316284
Company NameCLARUS MEDICAL, LLC
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
GS100810004820746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGEndoscope, Neurological

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-05
Device Publish Date2021-04-27

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