Perceval RELYON PAK PAK-XL

GUDID 08022057015563

Perceval RELYON PAK Size XL

CORCYM SRL

Heart valve prosthesis holder, single-use
Primary Device ID08022057015563
NIH Device Record Key21bbad74-1b61-411d-b9ca-06f56b0c1301
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerceval RELYON PAK
Version Model NumberPAK-XL
Catalog NumberPAK-XL
Company DUNS441454802
Company NameCORCYM SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS108022057015563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWRHeart-Valve, Non-Allograft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-21
Device Publish Date2022-11-11

On-Brand Devices [Perceval RELYON PAK ]

08022057015563Perceval RELYON PAK Size XL
08022057015556Perceval RELYON PAK Size L
08022057015549Perceval RELYON PAK Size M
08022057015532Perceval RELYON PAK Size S

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