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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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LOSPA IS Spinal Fixation System - 08800017253510

POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø7.0 X 115, Length 27.5mm
Corentec Co., Ltd
SA.227.7013
In Commercial Distribution

  • 08800017253510 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017253503

POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø7.0 X 110, Length 27.5mm
Corentec Co., Ltd
SA.227.7012
In Commercial Distribution

  • 08800017253503 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017253497

POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø7.0 X 105, Length 27.5mm
Corentec Co., Ltd
SA.227.7011
In Commercial Distribution

  • 08800017253497 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017253473

POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø7.0 X 95, Length 27.5mm
Corentec Co., Ltd
SA.227.7095
In Commercial Distribution

  • 08800017253473 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017253459

POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø7.0 X 85, Length 27.5mm
Corentec Co., Ltd
SA.227.7085
In Commercial Distribution

  • 08800017253459 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017253442

POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø7.0 X 80, Length 27.5mm
Corentec Co., Ltd
SA.227.7080
In Commercial Distribution

  • 08800017253442 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017253435

POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø7.0 X 75, Length 27.5mm
Corentec Co., Ltd
SA.227.7075
In Commercial Distribution

  • 08800017253435 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017253411

POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø7.0 X 65, Length 27.5mm
Corentec Co., Ltd
SA.227.7065
In Commercial Distribution

  • 08800017253411 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017253398

POLYAXIAL GUIDED PEDICLE SCREW II - Guided type Ø7.0 X 55, Length 27.5mm
Corentec Co., Ltd
SA.227.7055
In Commercial Distribution

  • 08800017253398 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017251714

POLYAXIAL PEDICLE SCREW II - standard type Ø7.0 X 120, Length 15.5mm
Corentec Co., Ltd
SA.226.7014
In Commercial Distribution

  • 08800017251714 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017251707

POLYAXIAL PEDICLE SCREW II - standard type Ø7.0 X 115, Length 15.5mm
Corentec Co., Ltd
SA.226.7013
In Commercial Distribution

  • 08800017251707 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017251691

POLYAXIAL PEDICLE SCREW II - standard type Ø7.0 X 110, Length 15.5mm
Corentec Co., Ltd
SA.226.7012
In Commercial Distribution

  • 08800017251691 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017251684

POLYAXIAL PEDICLE SCREW II - standard type Ø7.0 X 105, Length 15.5mm
Corentec Co., Ltd
SA.226.7011
In Commercial Distribution

  • 08800017251684 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017251677

POLYAXIAL PEDICLE SCREW II - standard type Ø7.0 X 100, Length 15.5mm
Corentec Co., Ltd
SA.226.7010
In Commercial Distribution

  • 08800017251677 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017251660

POLYAXIAL PEDICLE SCREW II - standard type Ø7.0 X 95, Length 15.5mm
Corentec Co., Ltd
SA.226.7095
In Commercial Distribution

  • 08800017251660 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017251653

POLYAXIAL PEDICLE SCREW II - standard type Ø7.0 X 90, Length 15.5mm
Corentec Co., Ltd
SA.226.7090
In Commercial Distribution

  • 08800017251653 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017251646

POLYAXIAL PEDICLE SCREW II - standard type Ø7.0 X 85, Length 15.5mm
Corentec Co., Ltd
SA.226.7085
In Commercial Distribution

  • 08800017251646 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017251639

POLYAXIAL PEDICLE SCREW II - standard type Ø7.0 X 80, Length 15.5mm
Corentec Co., Ltd
SA.226.7080
In Commercial Distribution

  • 08800017251639 ()


  • Spinal bone screw, non-bioabsorbable

LOSPA IS Spinal Fixation System - 08800017293554

Spinal Instrument - Probe
Corentec Co., Ltd
20203200
In Commercial Distribution

  • 08800017293554 ()


  • Surgical screwdriver, reusable

LOSPA IS Spinal Fixation System - 08800017292557

Spinal Instrument - PERSUADER 1 TYPE
Corentec Co., Ltd
SI.AP6.0043
In Commercial Distribution

  • 08800017292557 ()


  • Surgical screwdriver, reusable

LOSPA IS Spinal Fixation System - 08800017291970

Spinal Instrument - Power Gripper(6.0)
Corentec Co., Ltd
93007500
In Commercial Distribution

  • 08800017291970 ()


  • Surgical screwdriver, reusable

LOSPA IS Spinal Fixation System - 08800017291963

Spinal Instrument - TORQUE DRIVER FOR ROD LINK
Corentec Co., Ltd
SI.AP6.0021
In Commercial Distribution

  • 08800017291963 ()


  • Surgical screwdriver, reusable

LOSPA IS Spinal Fixation System - 08800017290522

Spinal Instrument - Vertebral plate Rongeur 4mm
Corentec Co., Ltd
20307600
In Commercial Distribution

  • 08800017290522 ()


  • Surgical screwdriver, reusable

LOSPA IS Spinal Fixation System - 08800017290515

"Spinal Instrument - Nucleus Pulposus forceps(Curved)4mm"
Corentec Co., Ltd
20307501
In Commercial Distribution

  • 08800017290515 ()


  • Surgical screwdriver, reusable

LOSPA IS Spinal Fixation System - 08800017290508

Spinal Instrument - Distractor
Corentec Co., Ltd
20506600
In Commercial Distribution

  • 08800017290508 ()


  • Surgical screwdriver, reusable

LOSPA IS Spinal Fixation System - 08800017290492

Spinal Instrument - Compressor
Corentec Co., Ltd
20506500
In Commercial Distribution

  • 08800017290492 ()


  • Surgical screwdriver, reusable

LOSPA IS Spinal Fixation System - 08800017288246

Spinal Instrument - MIS CAP
Corentec Co., Ltd
SI.MP6.0009
In Commercial Distribution

  • 08800017288246 ()


  • Internal spinal fixation procedure kit, reusable

LOSPA IS Spinal Fixation System - 08800017288239

Spinal Instrument - MIS GUIDE BREAKER
Corentec Co., Ltd
SI.MP6.0008
In Commercial Distribution

  • 08800017288239 ()


  • Surgical screwdriver, reusable

LOSPA IS Spinal Fixation System - 08800017288222

Spinal Instrument - MIS ANTI TORQUE HANDLE
Corentec Co., Ltd
SI.MP6.0007
In Commercial Distribution

  • 08800017288222 ()


  • Surgical screwdriver, reusable

LOSPA IS Spinal Fixation System - 08800017288215

Spinal Instrument - MIS FULCRUM
Corentec Co., Ltd
SI.MP6.0006
In Commercial Distribution

  • 08800017288215 ()


  • Surgical screwdriver, reusable

LOSPA IS Spinal Fixation System - 08800017288208

Spinal Instrument - MIS SLEEVE
Corentec Co., Ltd
SI.MP6.0005
In Commercial Distribution

  • 08800017288208 ()


  • Surgical screwdriver, reusable

LOSPA IS Spinal Fixation System - 08800017285566

Spinal Instrument - ROD ROCKER
Corentec Co., Ltd
SI.AP6.0041
In Commercial Distribution

  • 08800017285566 ()


  • Surgical screwdriver, reusable

Access Total BhCG (5th IS) - 15099590226213

The Access Total BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.
Beckman Coulter, Inc.
A85264
In Commercial Distribution

  • 15099590226213 ()
A85264

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay

Access TSH (3rd IS) Calibrators - 15099590671501

The Access TSH (3rd IS) Calibrators are intended to calibrate the Access TSH (3rd IS) assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems.
Beckman Coulter, Inc.
B63285
In Commercial Distribution

  • 15099590671501 ()
B63285

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

Access Total BhCG (5th IS) - 15099590744380

The Access Total BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.
Beckman Coulter, Inc.
C28645
In Commercial Distribution

  • 15099590744380 ()
C28645

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay

Neobiotech Implant System - 08809407157322

EB/IS, Ø7.0
Neobiotech. co., ltd
MP70
In Commercial Distribution

  • 08809407157322 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809407157315

EB/IS, Ø6.0
Neobiotech. co., ltd
MP60
In Commercial Distribution

  • 08809407157315 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809407157308

EB/IS, Ø5.5
Neobiotech. co., ltd
MP55
In Commercial Distribution

  • 08809407157308 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08800263106455

Ø4.5, 2.5HEX, IS
Neobiotech. co., ltd
DLAISRW
In Commercial Distribution

  • 08800263106455 ()


  • Dental implant suprastructure, temporary, preformed, single-use

Neobiotech Implant System - 08800263106325

Ø4.5, 2.5HEX, IS
Neobiotech. co., ltd
DLAISRWP
In Commercial Distribution

  • 08800263106325 ()


  • Dental implant suprastructure, temporary, preformed, single-use

Neobiotech Implant System - 08800263100163

IS/IT Type
Neobiotech. co., ltd
CG00L
In Commercial Distribution

  • 08800263100163 ()


  • Dental implant system

Neobiotech Implant System - 08809815656783

IS, Ø3.5, Narrow
Neobiotech. co., ltd
SGISFPT35N
In Commercial Distribution

  • 08809815656783 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815656776

IS, Ø4.0, Regular
Neobiotech. co., ltd
SGISFPT40R
In Commercial Distribution

  • 08809815656776 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815656769

IS, Ø4.5, Regular
Neobiotech. co., ltd
SGISFPT45R
In Commercial Distribution

  • 08809815656769 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815656752

IS, Ø5.0, Wide
Neobiotech. co., ltd
SGISFPT50W
In Commercial Distribution

  • 08809815656752 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815656714

IS, Ø4.0 Regular
Neobiotech. co., ltd
NGISCT40RS
In Commercial Distribution

  • 08809815656714 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815656707

IS, Ø5.0 Wide
Neobiotech. co., ltd
NGISCT50WS
In Commercial Distribution

  • 08809815656707 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815656585

IS, Ø3.5 Narrow
Neobiotech. co., ltd
NGISCT35NS
In Commercial Distribution

  • 08809815656585 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815656431

Ø3.8, Narrow, IS
Neobiotech. co., ltd
ISTD38L
In Commercial Distribution

  • 08809815656431 ()


  • Fixture/appliance dental drill bit, reusable

Neobiotech Implant System - 08809815656424

Ø4.3, Regular, IS
Neobiotech. co., ltd
ISTD43L
In Commercial Distribution

  • 08809815656424 ()


  • Fixture/appliance dental drill bit, reusable
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