OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US

GUDID 00358468000064

OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US

GENZYME CORPORATION

Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD
Primary Device ID00358468000064
NIH Device Record Keyf1811cc8-93f9-4566-a5de-8794cc7e1a87
Commercial Distribution StatusIn Commercial Distribution
Brand NameOLIPUDASE 20MG/5ML MEDSU VL1 DIAG US
Version Model Number785362
Company DUNS050424395
Company NameGENZYME CORPORATION
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 Numbertrue
Manufacturing Datefalse
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
GS100358468000064 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-09
Device Publish Date2020-07-01

Devices Manufactured by GENZYME CORPORATION

00358468000071 - GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US2022-10-27 GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US
00358468000057 - NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U2020-07-09 NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U
00358468000064 - OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US2020-07-09OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US
00358468000064 - OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US2020-07-09 OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US
00358468430120 - Seprafilm®2019-09-10 Barrier, Absorbable, Adhesion
00358468508621 - Seprafilm® Procedure Pack2019-09-10 Barrier, Absorbable, Adhesion
00358468638014 - Seprafilm® 4-section2019-09-10 Barrier, Absorbable, Adhesion
00358468664112 - Seprafilm® Single Site2019-09-10 Barrier, Absorbable, Adhesion
00358468664211 - Seprafilm® Small Incision2019-09-10 Barrier, Absorbable, Adhesion

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.