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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HemosIL Factor V Deficient Plasma (10 X 1 mL)
INSTRUMENTATION LABORATORY COMPANY
00020011500
In Commercial Distribution

  • 08426950484745 ()
  • 18426950484742 ()
00020011500

  • Coagulation factor V IVD, kit, clotting
No Description
DIAGNOSTICA STAGO
00744
In Commercial Distribution

  • 13607450007449 ()
  • 03607450007442 ()


  • Coagulation factor V IVD, kit, clotting
No Description
TCOAG IRELAND LIMITED
T1505
In Commercial Distribution

  • 15391521420388 ()
  • 05391521420381 ()


  • Coagulation factor V IVD, kit, clotting
CHOCOLATE with BAC / MTM BIPLT (Section I: Chocolate with Bacitracin; Section II: Modified Thayer Martin). For the selective isolation of fastidious bacteria.
HARDY DIAGNOSTICS
J101
Not in Commercial Distribution

  • 00816576020218 ()
  • 00816576021277 ()
J101

  • Haemophillus species agar identification medium IVD
For the determination of the activity of coagulation factor V in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873876
In Commercial Distribution

  • 00842768018886 ()
  • 00630414640754 ()
10873876

  • Coagulation factor V IVD, reagent
V Factor Disk, HardyDisks™, NAD disk to aid in the identification of Haemophilus spp., 50 disks per cartridge, 1 each Contains NAD (V factor) for the speciation of Haemophilus
HARDY DIAGNOSTICS
Z7041
In Commercial Distribution

  • 00816576028337 ()
  • 00816576028344 ()
Z7041

  • V factor differentiation disc IVD
No Description
HELENA LABORATORIES CORPORATION
5191
In Commercial Distribution

  • M52551910 ()


  • Coagulation factor V IVD, reagent
No Description
OXOID LIMITED
DD0004B
In Commercial Distribution

  • 05032384104659 ()


  • V factor differentiation disc IVD
No Description
OXOID LIMITED
DD0004T
In Commercial Distribution

  • 05032384034079 ()


  • V factor differentiation disc IVD
For the determination of the activity of coagulation factor V in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446271
In Commercial Distribution

  • 00842768009525 ()
  • 00842768018886 ()
ORSM23

  • Coagulation factor V IVD, reagent
George King Factor V Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor V donors.
GEORGE KING BIO-MEDICAL, INC
0500-200.0
In Commercial Distribution

  • 00815696021211 ()


  • Coagulation factor V IVD, reagent
George King Factor V Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor V deficient plasma
GEORGE KING BIO-MEDICAL, INC
0500-bulk
In Commercial Distribution

  • 00815696020917 ()


  • Coagulation factor V IVD, reagent
George King Factor V Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor V donors.
GEORGE KING BIO-MEDICAL, INC
0500-1.0
In Commercial Distribution

  • 00815696020023 ()


  • Coagulation factor V IVD, reagent
Ureteral Catheter Connecting Adapter
V L V ASSOCIATES (INC)
UCA5-95
In Commercial Distribution

  • 00850005780168 ()
UCA5-95

  • Ureteral/urethral catheter multichannel external connector
Wound Protector/ Retractor
V L V ASSOCIATES (INC)
1425-XS
In Commercial Distribution

  • B5911425XS3 ()
  • B5911425XS0 ()

  • 2 - 4cm


  • Radial surgical retractor
Wound Protector/ Retractor
V L V ASSOCIATES (INC)
1425-XL
In Commercial Distribution

  • B5911425XL3 ()
  • B5911425XL0 ()

  • 11 - 17cm


  • Radial surgical retractor
Wound Protector/ Retractor
V L V ASSOCIATES (INC)
1425-S
In Commercial Distribution

  • B5911425S3 ()
  • B5911425S0 ()

  • 2.5 - 6cm


  • Radial surgical retractor
Wound Protector/ Retractor
V L V ASSOCIATES (INC)
1425-M
In Commercial Distribution

  • B5911425M3 ()
  • B5911425M0 ()

  • 5 - 9cm


  • Radial surgical retractor
Wound Protector/ Retractor
V L V ASSOCIATES (INC)
1425-L
In Commercial Distribution

  • B5911425L3 ()
  • B5911425L0 ()

  • 9 - 14cm


  • Radial surgical retractor
Stryker NAV3(R) PLATFORM
Stryker Leibinger GmbH & Co. KG
7700-700-000
In Commercial Distribution

  • 04546540696427 ()
7700-700-000

  • Robotic surgical navigation system
Stryker ADAPT(R) PLATFORM
Stryker Leibinger GmbH & Co. KG
7700-600-000
In Commercial Distribution

  • 04546540696410 ()
7700-600-000

  • Multi-purpose stereotactic surgery system
No Description
HYPHEN BIOMED
222401
In Commercial Distribution

  • 03663537019074 ()
222401

  • Activated protein C resistant factor V (factor V Leiden) IVD, control
No Description
HYPHEN BIOMED
CK065K
In Commercial Distribution

  • 03663537017964 ()
CK065K

  • Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting
Coatest APC Resistance V-S
INSTRUMENTATION LABORATORY COMPANY
82 3138 63
In Commercial Distribution

  • 08426950076100 ()
82 3138 63

  • Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting
HemosIL Factor V Leiden (APC Resistance V)
INSTRUMENTATION LABORATORY COMPANY
00020008700
In Commercial Distribution

  • 08426950062424 ()
00020008700

  • Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting
Coatest APC Resistance
INSTRUMENTATION LABORATORY COMPANY
82 2643 63
Not in Commercial Distribution

  • 08426950060147 ()
82 2643 63

  • Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting
Coatest APC Resistance V
INSTRUMENTATION LABORATORY COMPANY
82 3120 63
In Commercial Distribution

  • 08426950060017 ()
82 3120 63

  • Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting
No Description
Precision Biologic Inc
APCR-05
In Commercial Distribution

  • 00843876000183 ()
  • 00843876010182 ()


  • Activated protein C resistant factor V (factor V Leiden) IVD, control
LEICA DI MICROSCOPE NAV. SYSTEM II KIT
Stryker Leibinger GmbH & Co. KG
7700-064-000
In Commercial Distribution

  • 04546540487339 ()
7700-064-000

  • Multi-purpose stereotactic surgery system
ZEISS NC4 MICRO.NAV.SYS. II SET
Stryker Leibinger GmbH & Co. KG
7700-054-000
In Commercial Distribution

  • 04546540487322 ()
7700-054-000

  • Multi-purpose stereotactic surgery system
SUCTION TUBE, 2.7MM LH FRONTAL SINUS
Stryker Leibinger GmbH & Co. KG
6001-088-427
In Commercial Distribution

  • 04546540350855 ()

  • Diameter: 2.7 Millimeter
6001-088-427

  • Stereotactic surgery system probe, reusable
SUCTION TUBE, 2.7MM RH FRONTAL SINUS
Stryker Leibinger GmbH & Co. KG
6001-088-327
In Commercial Distribution

  • 04546540350848 ()

  • Diameter: 2.7 Millimeter
6001-088-327

  • Stereotactic surgery system probe, reusable
ZEISS PENTERO MICR. NAV.SYSTEM II KIT
Stryker Leibinger GmbH & Co. KG
7700-074-000
In Commercial Distribution

  • 04546540432445 ()
7700-074-000

  • Multi-purpose stereotactic surgery system
ZEISS NC4 MICROSCOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-055-000
In Commercial Distribution

  • 07613252516941 ()
7700-055-000

  • Multi-purpose stereotactic surgery system
LEICA MICROSCOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-065-000
In Commercial Distribution

  • 07613252516934 ()
7700-065-000

  • Multi-purpose stereotactic surgery system
ZEISS PENTERO MICROSKOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-075-000
In Commercial Distribution

  • 07613252516927 ()
7700-075-000

  • Multi-purpose stereotactic surgery system
XV Factor, HardyDisks™, Hemin and NAD disk to aid in the identification of Haemophilus spp., 50 disks per cartridge, 1 each Contains NAD and Hemin (X and V Factors) for the speciation of Haemophilus.
HARDY DIAGNOSTICS
Z7051
In Commercial Distribution

  • 00816576028351 ()
  • 00816576028368 ()
Z7051

  • X/V factor differentiation disc IVD
No Description
OXOID LIMITED
DD0005B
In Commercial Distribution

  • 05032384105014 ()


  • X/V factor differentiation disc IVD
No Description
OXOID LIMITED
DD0005T
In Commercial Distribution

  • 05032384034109 ()


  • X/V factor differentiation disc IVD
BD BBL™ Taxo™ Differentiation Discs VX
BECTON, DICKINSON AND COMPANY
231731
In Commercial Distribution

  • 00382902317319 ()
231731

  • X/V factor differentiation disc IVD
BD BBL™ Taxo™ Differentiation Discs X
BECTON, DICKINSON AND COMPANY
231729
In Commercial Distribution

  • 00382902317296 ()
231729

  • X/V factor differentiation disc IVD
BD BBL™ Taxo™ Differentiation Discs V
BECTON, DICKINSON AND COMPANY
231727
In Commercial Distribution

  • 00382902317272 ()
231727

  • X/V factor differentiation disc IVD
HemosIL FII & FV DNA Control
INSTRUMENTATION LABORATORY COMPANY
00020003500
Not in Commercial Distribution

  • 08426950453086 ()
  • 18426950453083 ()
00020003500

  • Inherited thrombophilia IVD, control
Reusable SpO2 Sensor/百特/Soft Tip/Adult/3.0M/045
Unimed Medical Supplies, Inc.
U410S-12
In Commercial Distribution

  • 06945664802451 ()


  • Pulse oximeter probe, reusable
IBP interface cable/华南医电/Edwards/LP5/4.0M
Unimed Medical Supplies, Inc.
BC-HY-ED
In Commercial Distribution

  • 06945664869171 ()


  • Electrical-only medical device connection cable, reusable
eSensor® Thrombophilia Risk Test Reagent Test Pack (TRT) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Thrombophilia Risk Test Reagent Test (TRT)
Not in Commercial Distribution

  • 00857167005238 ()
MT004008

  • Multiple thrombophilia marker IVD, kit, clotting
eSensor® Thrombophilia Risk Test Amplification Reagents (TRT) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Thrombophilia Risk Test (TRT)
Not in Commercial Distribution

  • 00857167005221 ()
MT004008

  • Multiple thrombophilia marker IVD, kit, clotting
eSensor® Thrombophilia Risk Test Detection Reagents (TRT) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Thrombophilia Risk Test (TRT)
Not in Commercial Distribution

  • 00857167005214 ()
MT004008

  • Multiple thrombophilia marker IVD, kit, clotting
eSensor® Thrombophilia Risk Test (TRT) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Thrombophilia Risk Test (TRT)
Not in Commercial Distribution

  • 00857167005207 ()
MT004013

  • Multiple thrombophilia marker IVD, kit, clotting
eSensor® Thrombophilia Risk Test Cartridge Pouch (TRT) (8)
GENMARK DIAGNOSTICS, INC.
eSensor® Thrombophilia Risk Test (TRT)
Not in Commercial Distribution

  • 00857167005191 ()
KT021053

  • Multiple thrombophilia marker IVD, kit, clotting
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