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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Gelweave™ - 05037881059952

Gelweave Graft WITH RADIOPAQUE MARKERS
VASCUTEK LTD
7328148/10RME
In Commercial Distribution

  • 05037881059952 ()

  • Branch Diameter 8/14/10 mm
  • Lumen/Inner Diameter: 28 Millimeter
7328148/10RME

  • Synthetic vascular graft

Gelweave™ - 05037881059945

Gelweave Graft WITH RADIOPAQUE MARKERS
VASCUTEK LTD
7326148/10RME
In Commercial Distribution

  • 05037881059945 ()

  • Lumen/Inner Diameter: 26 Millimeter
  • Branch Diameter 8/14/10 mm
7326148/10RME

  • Synthetic vascular graft

Gelweave™ - 05037881059938

Gelweave Graft WITH RADIOPAQUE MARKERS
VASCUTEK LTD
7324148/10RME
In Commercial Distribution

  • 05037881059938 ()

  • Branch Diameter 8/14/10 mm
  • Lumen/Inner Diameter: 24 Millimeter
7324148/10RME

  • Synthetic vascular graft

Gelweave™ - 05037881059921

Gelweave Graft WITH RADIOPAQUE MARKERS
VASCUTEK LTD
7322148/10RME
In Commercial Distribution

  • 05037881059921 ()

  • Lumen/Inner Diameter: 22 Millimeter
  • Branch Diameter 8/14/10 mm
7322148/10RME

  • Synthetic vascular graft

Gelweave™ - 05037881059914

Gelweave Graft WITH RADIOPAQUE MARKERS
VASCUTEK LTD
7320148/10RME
In Commercial Distribution

  • 05037881059914 ()

  • Branch Diameter 8/14/10 mm
  • Lumen/Inner Diameter: 20 Millimeter
7320148/10RME

  • Synthetic vascular graft

Gelweave™ - 05037881048390

Gelweave Gelatin Impregnated Woven Vascular Prosthesis TRIFURCATE WITH SIDE BRANCH
VASCUTEK LTD
73128/10X2
In Commercial Distribution

  • 05037881048390 ()

  • Length: 30 Centimeter
  • Lumen/Inner Diameter: 12 Millimeter
73128/10X3

  • Synthetic vascular graft

Atellica CH OXY - 00630414238098

Oxycodone (OXY) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097541
In Commercial Distribution

  • 00630414238098 ()
11097541

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)

ADVIA Centaur® TSTO - 00630414235271

ADVIA Centaur® Testosterone (TSTO) Assay Kit 50T
Siemens Healthcare Diagnostics Inc.
11201912
Not in Commercial Distribution

  • 00630414235271 ()
11201912

  • Total testosterone IVD, kit, chemiluminescent immunoassay

Atellica CI Analyzer - 00630414229553

Atellica CI Analyzer
Siemens Healthcare Diagnostics Inc.
10947347
In Commercial Distribution

  • 00630414229553 ()
10947347

  • Multiple clinical chemistry analyser IVD, laboratory

ADVIA Centaur AMH Kit - 00630414225692

AMH - Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10998432
In Commercial Distribution

  • 00630414225692 ()
10998432

  • Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur MH MCM Set - 00630414225685

AMH - Centaur - Master Curve Material Kit 4 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10998430
In Commercial Distribution

  • 00630414225685 ()
10998430

  • Anti-Mullerian hormone (AMH) IVD, control

ADVIA® 120/2120/2120i SETpoint - 00630414224343

ADVIA®120/2120/2120i SETpoint™
Siemens Healthcare Diagnostics Inc.
10312285
In Commercial Distribution

  • 00630414224343 ()
T03-3685-52

  • Full blood count IVD, calibrator

ADVIA 120/2120/2120i® OPTIpoint - 00630414224329

ADVIA®120/2120/2120i OPTIpoint™
Siemens Healthcare Diagnostics Inc.
10312283
In Commercial Distribution

  • 00630414224329 ()
T03-3682-54

  • Full blood count IVD, calibrator

ADVIA 120/2120/2120i® OPTIpoint - 00630414224305

ADVIA®120/2120/2120i OPTIpoint™
Siemens Healthcare Diagnostics Inc.
10319591
In Commercial Distribution

  • 00630414224305 ()
T03-3682-01

  • Full blood count IVD, calibrator

ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC - 00630414222950

IVD Complete Blood Count Kit CN-FREE
Siemens Healthcare Diagnostics Inc.
10341169
In Commercial Distribution

  • 00630414222950 ()
T01-3626-52

  • Full blood count IVD, kit, cell count

ADVIA 120/2120/2120i® Defoamer - 00630414222943

ADVIA®120/2120/2120i DEFOAMER
Siemens Healthcare Diagnostics Inc.
10312274
In Commercial Distribution

  • 00630414222943 ()
T01-3625-54

  • Full blood count IVD, reagent

IMMULITE 2000 Third Generation TSH - 00630414210841

TSH - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11129119
In Commercial Distribution

  • 00630414210841 ()
L2KTS6(D)

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 Third Generation TSH - 00630414210834

TSH - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11129118
In Commercial Distribution

  • 00630414210834 ()
L2KTS2(D)

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

ADVIA® Chemistry ISE Urine Standard Set - 00630414210247

ISE Standard Urine - ADVIA Chem. - CAL - 2x100mL
Siemens Healthcare Diagnostics Inc.
10311904
In Commercial Distribution

  • 00630414210247 ()
B03-4176-01

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)

ADVIA® Chemistry ISE Serum Standard Set - 00630414210230

ISE Standard Serum - ADVIA Chem. - CAL - 2x100mL
Siemens Healthcare Diagnostics Inc.
10311903
In Commercial Distribution

  • 00630414210230 ()
B03-4175-01

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)

ADVIA® Chemistry APO A1/B Calibrator - 00630414210131

ApolipoproteinA1/B - ADVIA Chem. - CAL - 5x1mL
Siemens Healthcare Diagnostics Inc.
10311898
In Commercial Distribution

  • 00630414210131 ()
  • 00630414003436 ()
B03-4161-01

  • Multiple apolipoprotein IVD, calibrator

ADVIA® Chemistry ISE Buffer - 2 liter - 00630414209968

ISE Buffer - ADVIA Chem. - CONS - 2 Liter
Siemens Healthcare Diagnostics Inc.
10311849
In Commercial Distribution

  • 00630414209968 ()
B01-4171-51

  • pH-adjusted buffer solution IVD

ADVIA Centaur® FSH - 00630414204666

ADVIA Centaur® FSH (5-pack)
Siemens Healthcare Diagnostics Inc.
10337964
In Commercial Distribution

  • 00630414204666 ()
  • 00630414010601 ()
118821

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® LH - 00630414204628

Lutenizing Hormone (Ref) - CENTAUR - RGT - 300 tests
Siemens Healthcare Diagnostics Inc.
10332181
In Commercial Distribution

  • 00630414204628 ()
  • 00630414010595 ()
118826

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

Gelweave™ - 05037881017174

Gelweave Gelatin Impregnated Woven Vascular Prosthesis THORACIC ARCH GRAFT WITH RADIOPAQUE MARKER
VASCUTEK LTD
732214/10/10CRM
In Commercial Distribution

  • 05037881017174 ()

  • Branch diameter 10/10 mm
  • Length: 22 Centimeter
  • Branch length 25/13 cm
  • Lumen/Inner Diameter: 14 Millimeter
732214/10/10CRM

  • Synthetic vascular graft

ADVIA Centaur® PRGE - 00630414204147

Progesterone - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310305
In Commercial Distribution

  • 00630414204147 ()
118530

  • Progesterone IVD, kit, chemiluminescent immunoassay

Gelweave™ - 05037881017167

Gelweave Gelatin Impregnated Woven Vascular Prosthesis THORACIC ARCH GRAFT WITH RADIOPAQUE MARKER
VASCUTEK LTD
732212/10/8CRM
In Commercial Distribution

  • 05037881017167 ()

  • Lumen/Inner Diameter: 12 Millimeter
  • Length: 22 Centimeter
  • Branch diameter 10/8 mm
  • Branch length 25/13 cm
732212/10/8CRM

  • Synthetic vascular graft

Gelweave™ - 05037881016894

Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS WITH ANTE-FLO AND RADIOPAQUE
VASCUTEK LTD
73140778/8RM
In Commercial Distribution

  • 05037881016894 ()

  • Branch diameter 7/7/7/8/8 mm
  • Branch length 30/30/15/15/15 cm
  • Lumen/Inner Diameter: 14 Millimeter
  • Length: 15 Centimeter
73140778/8RM

  • Synthetic vascular graft

Gelweave™ - 05037881015705

Gelweave Gelatin Impregnated Woven Vascular Prosthesis GELWEAVE 3 BRANCH PLEXUS WITH RADIOPAQUE MARKERS
VASCUTEK LTD
7332128/10RMB
In Commercial Distribution

  • 05037881015705 ()

  • Branch Length 15/15/15 mm
  • Branch Diameter 12/8/10 mm
  • Length: 40 Centimeter
  • Lumen/Inner Diameter: 32 Millimeter
7332128/10RMB

  • Synthetic vascular graft

Gelweave™ - 05037881015699

Gelweave Gelatin Impregnated Woven Vascular Prosthesis GELWEAVE 3 BRANCH PLEXUS WITH RADIOPAQUE MARKERS
VASCUTEK LTD
7330128/10RMB
In Commercial Distribution

  • 05037881015699 ()

  • Branch length 15/15/15 cm
  • Branch diameter 12/8/10 mm
  • Lumen/Inner Diameter: 30 Millimeter
  • Length: 40 Centimeter
7330128/10RMB

  • Synthetic vascular graft
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