Artegraft Vascular Graft AG 830

GUDID 00316837000367

7mm x 30cm

Artegraft Inc

Arteriovenous shunt
Primary Device ID00316837000367
NIH Device Record Key0190671d-7d2b-4915-a70a-71daf208f4c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameArtegraft Vascular Graft
Version Model NumberAG 830
Catalog NumberAG 830
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
GS100316837000367 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-06
Device Publish Date2019-07-29

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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