Artegraft Vascular Graft AG 630

GUDID 00316837000220

5mm x 30cm

Artegraft Inc

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Primary Device ID00316837000220
NIH Device Record Keybf5a02b7-7957-411e-b5c2-cb0ae1e84853
Commercial Distribution StatusIn Commercial Distribution
Brand NameArtegraft Vascular Graft
Version Model NumberAG 630
Catalog NumberAG 630
Company DUNS003683646
Company NameArtegraft Inc
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
GS100316837000220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXATissue Graft Of 6mm And Greater

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 Date2014-08-29

On-Brand Devices [Artegraft Vascular Graft]

003168370003508mm x 30 Cm
003168370003438mm x 15 cm
003168370003367mm x 45 cm
003168370003297mm x 40 cm
003168370003126mm x 50cm
003168370003056mm x 45 cm
003168370002996mm x 40 cm
003168370002826mm x 35 cm
003168370002756mm x 30cm
003168370002686mm x 15 cm
003168370002515mm x 45 cm
00316837000244Artegraft Vascular Graft 5mm x 40 cm
003168370002375mm x 35cm
003168370002205mm x 30cm
003168370002135mm x 16 cm
003168370002064mm x 40 cm
003168370001904mm x 35cm
003168370003677mm x 30cm

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