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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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Inertia® Pedicle Screw System - 00889929005385

One Shot Pedicle Screw, Ø6.5mm x 40mm
NEXXT SPINE, LLC
10-20-6540
In Commercial Distribution

  • 00889929005385 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 40 Millimeter
  • One Shot


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005378

One Shot Pedicle Screw, Ø6.5mm x 35mm
NEXXT SPINE, LLC
10-20-6535
In Commercial Distribution

  • 00889929005378 ()

  • One Shot
  • Length: 35 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005361

One Shot Pedicle Screw, Ø6.5mm x 30mm
NEXXT SPINE, LLC
10-20-6530
In Commercial Distribution

  • 00889929005361 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 30 Millimeter
  • One Shot


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005354

One Shot Pedicle Screw, Ø5.75mm x 40mm
NEXXT SPINE, LLC
10-20-5740
In Commercial Distribution

  • 00889929005354 ()

  • One Shot
  • Length: 40 Millimeter
  • Outer Diameter: 5.75 Millimeter


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005347

One Shot Pedicle Screw, Ø5.75mm x 35mm
NEXXT SPINE, LLC
10-20-5735
In Commercial Distribution

  • 00889929005347 ()

  • Outer Diameter: 5.75 Millimeter
  • Length: 35 Millimeter
  • One Shot


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005323

One Shot Pedicle Screw, Ø5.5mm x 55mm
NEXXT SPINE, LLC
10-20-5555
In Commercial Distribution

  • 00889929005323 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 55 Millimeter
  • One Shot


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005316

One Shot Pedicle Screw, Ø5.5mm x 50mm
NEXXT SPINE, LLC
10-20-5550
In Commercial Distribution

  • 00889929005316 ()

  • One Shot
  • Length: 50 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005286

One Shot Pedicle Screw, Ø5.5mm x 35mm
NEXXT SPINE, LLC
10-20-5535
In Commercial Distribution

  • 00889929005286 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter
  • One Shot


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005279

One Shot Pedicle Screw, Ø5.5mm x 30mm
NEXXT SPINE, LLC
10-20-5530
In Commercial Distribution

  • 00889929005279 ()

  • One Shot
  • Length: 30 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929010129

One Shot, Pedicle Screw, Ø7.5mm x 70mm
NEXXT SPINE, LLC
10-20-7570
In Commercial Distribution

  • 00889929010129 ()

  • One Shot
  • Length: 70 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929010112

One Shot, Pedicle Screw, Ø7.5mm x 65mm
NEXXT SPINE, LLC
10-20-7565
In Commercial Distribution

  • 00889929010112 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 65 Millimeter
  • One Shot


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929010099

One Shot, Pedicle Screw, Ø7.0mm x 70mm
NEXXT SPINE, LLC
10-20-7070
In Commercial Distribution

  • 00889929010099 ()

  • Outer Diameter: 7 Millimeter
  • Length: 70 Millimeter
  • One Shot


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929010082

One Shot, Pedicle Screw, Ø7.0mm x 65mm
NEXXT SPINE, LLC
10-20-7065
In Commercial Distribution

  • 00889929010082 ()

  • One Shot
  • Length: 65 Millimeter
  • Outer Diameter: 7 Millimeter


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005637

One Shot Pedicle Screw, Ø7.5mm x 60mm
NEXXT SPINE, LLC
10-20-7560
In Commercial Distribution

  • 00889929005637 ()

  • One Shot
  • Length: 60 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005620

One Shot Pedicle Screw, Ø7.5mm x 55mm
NEXXT SPINE, LLC
10-20-7555
In Commercial Distribution

  • 00889929005620 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 55 Millimeter
  • One Shot


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005613

One Shot Pedicle Screw, Ø7.5mm x 50mm
NEXXT SPINE, LLC
10-20-7550
In Commercial Distribution

  • 00889929005613 ()

  • One Shot
  • Length: 50 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005606

One Shot Pedicle Screw, Ø7.5mm x 45mm
NEXXT SPINE, LLC
10-20-7545
In Commercial Distribution

  • 00889929005606 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 45 Millimeter
  • One Shot


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005590

One Shot Pedicle Screw, Ø7.5mm x 40mm
NEXXT SPINE, LLC
10-20-7540
In Commercial Distribution

  • 00889929005590 ()

  • One Shot
  • Length: 40 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005583

One Shot Pedicle Screw, Ø7.5mm x 35mm
NEXXT SPINE, LLC
10-20-7535
In Commercial Distribution

  • 00889929005583 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 35 Millimeter
  • One Shot


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005576

One Shot Pedicle Screw, Ø7.5mm x 30mm
NEXXT SPINE, LLC
10-20-7530
In Commercial Distribution

  • 00889929005576 ()

  • One Shot
  • Length: 30 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005507

One Shot Pedicle Screw, Ø7.0mm x 30mm
NEXXT SPINE, LLC
10-20-7030
In Commercial Distribution

  • 00889929005507 ()

  • Outer Diameter: 7 Millimeter
  • Length: 30 Millimeter
  • One Shot


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005330

One Shot Pedicle Screw, Ø5.5mm x 60mm
NEXXT SPINE, LLC
10-20-5560
In Commercial Distribution

  • 00889929005330 ()

  • One Shot
  • Length: 60 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005309

One Shot Pedicle Screw, Ø5.5mm x 45mm
NEXXT SPINE, LLC
10-20-5545
In Commercial Distribution

  • 00889929005309 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 45 Millimeter
  • One Shot


  • Spinal bone screw, non-bioabsorbable

Inertia® Pedicle Screw System - 00889929005293

One Shot Pedicle Screw, Ø5.5mm x 40mm
NEXXT SPINE, LLC
10-20-5540
In Commercial Distribution

  • 00889929005293 ()

  • One Shot
  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Spinal bone screw, non-bioabsorbable

Mölnlycke® Z-Flex™ Fluidized Heel Boot - 07323190250554

Fluidized Heel Boot
Mölnlycke Health Care AB
1400123
In Commercial Distribution

  • 07323190249558 ()
  • 07323190250554 ()

  • One size


  • Foot friction/impact protector

Mölnlycke® Z-Flex™ Fluidized Heel Boot - 07323190250547

Fluidized Heel Boot
Mölnlycke Health Care AB
1400122
In Commercial Distribution

  • 07323190249510 ()
  • 07323190250547 ()

  • One size


  • Foot friction/impact protector

LABType™ XR Class I B Locus Typing Test - 00814695022687

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022687 ()
RSSOX1B

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABType™ XR Class I A Locus Typing Test - 00814695022670

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022670 ()
RSSOX1A

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABType™ CWD Class I DRB1 Locus Typing - 00814695022663

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022663 ()
RSSOW2B1

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABType™ CWD Class I C Locus Typing Test - 00814695022656

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022656 ()
RSSOW1C

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABType™ CWD Class I A Locus Typing Test - 00814695022632

DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022632 ()
RSSOW1A

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABScan3D™ - 00814695022588

Dual syringe pumps and reagent reservoirs allow for higher throughput and planned maintenance routines. With its ability to process 500 bead regions simultaneously, there is significant increase in the size of screenable analytes.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022588 ()
LABSCNXS4

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

HLA Fusion™ Software (IVD) - 00814695022571

HLA Fusion Software for clinical diagnostics features analysis modules for One Lambda’s IVD products such as FlowPRA®, LABScreen®, LABType®, LCT™, Micro SSP™ and more.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022571 ()
FUSPGR

  • HLA class I & II antibody screening IVD, kit, multiplex
  • HLA class I & II antigen tissue typing IVD, kit, multiplex

SeCore™ GSSP Kit - 00814695022519

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022519 ()
A11256

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

UniMatch™ Plus Software - 00814695022496

UniMatch PLUS Software analyzes the reaction patterns of UniTray™ and AllSet+™ Gold kits for the determination of Human Leukocyte Antigens (HLA) allele assignment by comparison to the IMGT/HLA database.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022496 ()
790111

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP DQB1*02/04 High Resolution Kit - 00814695022274

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022274 ()
542130D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP DRB5 High Resolution Kit - 00814695022267

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022267 ()
542120D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP DRB4 High Resolution Kit - 00814695022250

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022250 ()
542110D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP DRB1*01 High Resolution Kit - 00814695022243

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022243 ()
54210D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP DRB3 High Resolution Kit - 00814695022236

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022236 ()
542100D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP B*40 High Resolution Kit - 00814695022229

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022229 ()
54190D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP B*51/52 High Resolution Kit - 00814695022212

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022212 ()
54180D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP A*23/24 High Resolution Kit - 00814695022205

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022205 ()
54170D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP A*23/24 High Resolution Kit - 00814695022199

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022199 ()
54160D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP B*44/45 High Resolution Kit - 00814695022182

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022182 ()
54150D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP B*35 High Resolution Kit - 00814695022175

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022175 ()
54140D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP A*19 High Resolution Kit - 00814695022168

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022168 ()
54130D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP B*21 High Resolution Kit - 00814695022151

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022151 ()
541230D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP B*13 High Resolution Kit - 00814695022144

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022144 ()
541220D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

AllSet+™ Gold SSP A*68 High Resolution Kit - 00814695022137

AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022137 ()
541210D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
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