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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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The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
NANOSPHERE, INC.
20-006-001
Not in Commercial Distribution

  • 00857573006027 ()


  • Multiple coagulation factor IVD, kit, clotting
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
LUMINEX CORPORATION
30-001-001
Not in Commercial Distribution

30-001-001

  • Multiple coagulation factor IVD, kit, clotting
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
LUMINEX CORPORATION
20-006-001
Not in Commercial Distribution

20-006-001

  • Multiple coagulation factor IVD, kit, clotting
ANA Pattern Control Panel II
IMMCO DIAGNOSTICS, INC.
1602
In Commercial Distribution

  • 00845714002168 ()

  • 5 x .5 ml
1602

  • Multiple antinuclear antibody (ANA) screening IVD, reagent
WEB 21 SL 5x5
SEQUENT MEDICAL, INC.
W4-5-5
In Commercial Distribution

  • 00854111006082 ()

  • 5 x 5 mm
FGA25050-050

  • Neurovascular embolization coil
HEDY Polyisoprene Dental Dam - Non-Latex - 5"x 5" - Medium - Blue
AMD Medicom Inc
320DNB-5M
In Commercial Distribution

  • 00686864060420 ()
  • 10686864060427 ()
  • 20686864060424 ()

  • 5 X 5 Inch
320DNB-5M

  • Rubber dam, non-latex
HEDY Polyisoprene Dental Dam - Non-Latex - 5"x 5" - Heavy - Blue
AMD Medicom Inc
320DNB-5H
In Commercial Distribution

  • 00686864060413 ()
  • 10686864060410 ()
  • 20686864060417 ()

  • 5 X 5 Inch
320DNB-5H

  • Rubber dam, non-latex
HEDY DENTAL DAM - Natural Rubber Latex - 5"x5" - Thin - Blue
AMD Medicom Inc
310DB-5T
In Commercial Distribution

  • 00686864060314 ()
  • 10686864060311 ()

  • 5 X 5 Inch
310DB-5T

  • Rubber dam, Hevea-latex
HEDY DENTAL DAM - Natural Rubber Latex - 5"x5" - Medium - Blue
AMD Medicom Inc
310DB-5M
In Commercial Distribution

  • 00686864060307 ()
  • 10686864060304 ()

  • 5 X 5 Inch
310DB-5M

  • Rubber dam, Hevea-latex
HEDY DENTAL DAM - Natural Rubber Latex - 5"x5" - Heavy - Blue
AMD Medicom Inc
310DB-5H
In Commercial Distribution

  • 00686864060291 ()
  • 10686864060298 ()

  • 5 x 5 Inch
310DB-5H

  • Rubber dam, Hevea-latex
MK femoral spacer posterior incl. screw
implantcast GmbH
57225005
In Commercial Distribution

  • 04048844214494 ()

  • sz. 5 / 5 mm


  • Knee arthroplasty wedge
MK femoral spacer distal ll/rm incl. screw
implantcast GmbH
57225505
In Commercial Distribution

  • 04048844214623 ()

  • sz. 5 / 5 mm


  • Knee arthroplasty wedge
MK femoral spacer distal rl/lm incl. screw
implantcast GmbH
57220505
In Commercial Distribution

  • 04048844152420 ()

  • sz. 5 / 5 mm


  • Knee arthroplasty wedge
MK femoral spacer distal rl/lm
implantcast GmbH
5722050500
In Commercial Distribution

  • 04048844590079 ()

  • sz. 5 / 5 mm


  • Knee arthroplasty wedge
MK femoral spacer posterior
implantcast GmbH
5722500500
In Commercial Distribution

  • 04048844589479 ()

  • sz. 5 / 5 mm


  • Knee arthroplasty wedge
MK femoral spacer distal ll/rm
implantcast GmbH
5722550500
In Commercial Distribution

  • 04048844589769 ()

  • sz. 5 / 5 mm


  • Knee arthroplasty wedge
MILLER RASPATORY DOUBLE ENDED SERRATED TIP
SONTEC INSTRUMENTS, INC.
1100-490
In Commercial Distribution

  • 00192896047792 ()

  • 5/5 Millimeter Tips
  • Length: 7.125 Inch
1100-490

  • Bone file/rasp, manual, reusable
LEGION OXINIUM CONSTRAINED FEMORAL SIZE 5 RIGHT
Smith & Nephew, Inc.
71421175
In Commercial Distribution

  • 03596010543912 ()

  • Size 5: Size 5
71421175

  • Uncoated knee femur prosthesis, metallic
LEGION OXINIUM CONSTRAINED FEMORAL SIZE 5 LEFT
Smith & Nephew, Inc.
71421165
In Commercial Distribution

  • 03596010543844 ()

  • Size 5: Size 5
71421165

  • Uncoated knee femur prosthesis, metallic
JOURNEY II UK LATERAL TIBIA BASEPLATE SIZE 5 RIGHT
Smith & Nephew, Inc.
74026145
In Commercial Distribution

  • 00885556676967 ()

  • SIZE 5: SIZE 5
74026145

  • Uncoated unicondylar knee tibia prosthesis, metallic
JOURNEY II UK LATERAL TIBIA BASEPLATE SIZE 5 LEFT
Smith & Nephew, Inc.
74026135
In Commercial Distribution

  • 00885556676882 ()

  • Size 5: Size 5
74026135

  • Uncoated unicondylar knee tibia prosthesis, metallic
JOURNEY II UK OXINIUM FEMORAL SIZE 5 RIGHT MEDIAL/LEFT LATERAL
Smith & Nephew, Inc.
74026035
In Commercial Distribution

  • 00885556675885 ()

  • Size 5: Size 5
74026035

  • Uncoated unicondylar knee femur prosthesis
No Description
Eckert & Ziegler BEBIG GmbH
LLH02-22#04
Not in Commercial Distribution

  • 04049223108175 ()
LLH02-22

  • General-purpose brachytherapy system applicator, remote-afterloading
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
CT-356039002
In Commercial Distribution

  • 00842430103094 ()
CT-356039002

  • Operating table mattress, basic
Trial sledge 5°
CORIN LTD
MDF617
In Commercial Distribution

  • 05056139216985 ()
MDF617

  • Orthopaedic prosthesis implantation positioning instrument, reusable
ScanPeg – 5 pcs
Neoss AB
31365
In Commercial Distribution

  • 05060440333644 ()
31365

  • Dental implant suprastructure, temporary, preformed, single-use
5 pcs/box
CORETESTS, INC.
Multi-panel
In Commercial Distribution

  • 10850042559021 ()
  • 00850042559024 ()


  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
  • 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)
  • Amphetamine/methamphetamine group IVD, kit, chemiluminescent immunoassay
  • Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
RASP SIZE 5
CORIN LTD
695.1050
In Commercial Distribution

  • 05055343884188 ()
695.1050

  • Bone file/rasp, manual, reusable
Size 5 Broach
CORIN LTD
580.9435
In Commercial Distribution

  • 05055343891919 ()
580.9435

  • Orthopaedic broach
Tubing 3.5Fr. 5"
BIOSEAL
4923/10
In Commercial Distribution

  • 10630094049233 ()
  • 00630094049236 ()


  • Oxygen administration tubing
Power Cord 5
MIZUHO CORPORATION
18-045-05
In Commercial Distribution

  • 04946329297805 ()

  • Length: 460 Millimeter
18-045-05

  • Electrical mains power cable
KIT, ANESTHESIA 5
Cardinal Health 200, LLC
AN1358095B
In Commercial Distribution

  • 50888439964774 ()
  • 10888439964776 ()
AN1358095B

  • General surgical procedure kit, non-medicated, single-use
ANESTHESIA KIT 5
Cardinal Health 200, LLC
AN1358095A
In Commercial Distribution

  • 50888439946015 ()
  • 10888439946017 ()
AN1358095A

  • General surgical procedure kit, non-medicated, single-use
Tubing 3.5Fr. 5"
BIOSEAL
4905/10
In Commercial Distribution

  • 10630094490516 ()
  • 00630094490519 ()


  • Oxygen administration tubing
CATARACT 5 PACK
Cardinal Health 200, LLC
SEY53CTOEL
In Commercial Distribution

  • 50888439534717 ()
  • 10888439534719 ()
SEY53CTOEL

  • Ophthalmic surgical procedure kit, medicated, single-use
INITIA BROACH 5
KYOCERA CORPORATION
TJ39646-1
In Commercial Distribution

  • 04547898735264 ()

  • Size: #5
TJ39646-1

  • Joint prosthesis implantation kit, reusable
CATARACT 5 PACK
Cardinal Health 200, LLC
SEY53CTOEM
In Commercial Distribution

  • 50888439640722 ()
  • 10888439640724 ()
SEY53CTOEM

  • Ophthalmic surgical procedure kit, medicated, single-use
5 PK Thomas
HU-FRIEDY MFG. CO., LLC
PKT58
Not in Commercial Distribution

  • 10889950138424 ()


  • Dental wax carver
#5 Hemostat (1x2)
HU-FRIEDY MFG. CO., LLC
H5
In Commercial Distribution

  • 10889950013363 ()
H5

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
#5 DE Explorer
HU-FRIEDY MFG. CO., LLC
EXD5
In Commercial Distribution

  • 10889950011123 ()
EXD5

  • Dental surgical probe, reusable
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