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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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MESA® Spinal System - 10888857264281

MESA 2 Deformity Polyaxial Screw Size Ø10.5x40 mm
K2M, INC.
6201-01040-G1
In Commercial Distribution

  • 10888857264281 ()

  • Outer Diameter: 10.5 Millimeter
  • Length: 40 Millimeter
6201-01040-G1

  • Spinal bone screw, non-bioabsorbable

MESA® Spinal System - 10888857264274

MESA 2 Deformity Polyaxial Screw Size Ø10.5x35 mm
K2M, INC.
6201-01035-G1
In Commercial Distribution

  • 10888857264274 ()

  • Length: 35 Millimeter
  • Outer Diameter: 10.5 Millimeter
6201-01035-G1

  • Spinal bone screw, non-bioabsorbable

MESA® Spinal System - 10888857264267

MESA 2 Deformity Polyaxial Screw Size Ø10.5x30 mm
K2M, INC.
6201-01030-G1
In Commercial Distribution

  • 10888857264267 ()

  • Length: 30 Millimeter
  • Outer Diameter: 10.5 Millimeter
6201-01030-G1

  • Spinal bone screw, non-bioabsorbable

MESA® Spinal System - 10888857264250

MESA 2 Deformity Polyaxial Screw Size Ø10.5x25 mm
K2M, INC.
6201-01025-G1
In Commercial Distribution

  • 10888857264250 ()

  • Length: 25 Millimeter
  • Outer Diameter: 10.5 Millimeter
6201-01025-G1

  • Spinal bone screw, non-bioabsorbable

MESA® Spinal System - 10888857264243

MESA 2 Deformity Polyaxial Screw Size Ø9.5x110 mm
K2M, INC.
6201-095110-G1
In Commercial Distribution

  • 10888857264243 ()

  • Length: 110 Millimeter
  • Outer Diameter: 9.5 Millimeter
6201-095110-G1

  • Spinal bone screw, non-bioabsorbable

MESA® Spinal System - 10888857264236

MESA 2 Deformity Polyaxial Screw Size Ø9.5x105 mm
K2M, INC.
6201-095105-G1
In Commercial Distribution

  • 10888857264236 ()

  • Length: 105 Millimeter
  • Outer Diameter: 9.5 Millimeter
6201-095105-G1

  • Spinal bone screw, non-bioabsorbable

MESA® Spinal System - 10888857264229

MESA 2 Deformity Polyaxial Screw Size Ø9.5x100 mm
K2M, INC.
6201-095100-G1
In Commercial Distribution

  • 10888857264229 ()

  • Length: 100 Millimeter
  • Outer Diameter: 9.5 Millimeter
6201-095100-G1

  • Spinal bone screw, non-bioabsorbable

MESA® Spinal System - 10888857264212

MESA 2 Deformity Polyaxial Screw Size Ø9.5x95 mm
K2M, INC.
6201-09595-G1
In Commercial Distribution

  • 10888857264212 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 95 Millimeter
6201-09595-G1

  • Spinal bone screw, non-bioabsorbable

HLS Uni Evolution - 05056139208423

HLS uni Evolution Tibial component PE Size 5 Th11mm
CORIN LTD
GDU154
In Commercial Distribution

  • 05056139208423 ()
GDU154

  • Uncoated unicondylar knee tibia prosthesis, polyethylene

MESA® Spinal System - 10888857264199

MESA 2 Deformity Polyaxial Screw Size Ø9.5x85 mm
K2M, INC.
6201-09585-G1
In Commercial Distribution

  • 10888857264199 ()

  • Outer Diameter: 9.5 Millimeter
  • Length: 85 Millimeter
6201-09585-G1

  • Spinal bone screw, non-bioabsorbable

HLS Uni Evolution - 05056139208393

HLS uni Evolution Tibial component PE Size 4 Th11mm
CORIN LTD
GDU144
In Commercial Distribution

  • 05056139208393 ()
GDU144

  • Uncoated unicondylar knee tibia prosthesis, polyethylene

Duckworth & Kent - 05055313809098

Sterilising Case
DUCKWORTH AND KENT LIMITED
6-135
Not in Commercial Distribution

  • 05055313809098 ()
6-135

  • Instrument tray, reusable

Duckworth & Kent - 05055313803782

Lid Clamp
DUCKWORTH AND KENT LIMITED
2-640
Not in Commercial Distribution

  • 05055313803782 ()
2-640

  • Eyelid clamp, reusable

Duckworth & Kent - 05055313800385

Corneal Scissors
DUCKWORTH AND KENT LIMITED
1-410
Not in Commercial Distribution

  • 05055313800385 ()
1-410

  • Corneal scissors, reusable

Duckworth & Kent - 05055313800279

Corneal Scissors
DUCKWORTH AND KENT LIMITED
1-219
In Commercial Distribution

  • 05055313800279 ()
1-219

  • Corneal scissors, reusable

Duckworth & Kent - 05055313800262

Corneal Scissors
DUCKWORTH AND KENT LIMITED
1-218
In Commercial Distribution

  • 05055313800262 ()
1-218

  • Corneal scissors, reusable

Duckworth & Kent - 05055313800118

Corneal Scissors
DUCKWORTH AND KENT LIMITED
1-118
In Commercial Distribution

  • 05055313800118 ()
1-118

  • Corneal scissors, reusable

Single Use Surgical Professional - 05055299105498

Kerrison Punch 3mm x 170mm @ 90 Degrees
EAKIN SURGICAL LIMITED
S368
Not in Commercial Distribution

  • 05055299105498 ()
  • 05055299105603 ()

  • Bite Size 3mm
  • Angle: 90 degree
  • Length: 170 Millimeter
S368

  • Bone-coring punch, single-use

Single Use Professional - 05055299105474

Kerrison Rongeur 2mm x 170mm 90° contains 6 units
EAKIN SURGICAL LIMITED
S367
In Commercial Distribution

  • 05055299105474 ()

  • Length: 170 Millimeter
  • Bite Size 4mm
  • Angle: 90 degree
S367

  • Bone-coring punch, single-use

Single Use Professional - 05055299104439

Kerrison Rongeur 3mm x 200mm 45° DUO contains 6 units
EAKIN SURGICAL LIMITED
S262
In Commercial Distribution

  • 05055299104439 ()

  • Bite Size 3mm
  • Angle: 45 degree
  • Length: 200 Millimeter
S262

  • Bone-coring punch, single-use

Single Use Professional - 05055299104415

Kerrison Rongeur 2mm x 200mm 45° DUO contains 6 units
EAKIN SURGICAL LIMITED
S261
In Commercial Distribution

  • 05055299104415 ()

  • Bite Size 2mm
  • Angle: 45 degree
  • Length: 200 Millimeter
S261

  • Bone-coring punch, single-use

Single Use Professional - 05055299102213

Kerrison Rongeur 3mm x 200mm 45° contains 6 units
EAKIN SURGICAL LIMITED
S127
In Commercial Distribution

  • 05055299102213 ()

  • Angle: 45 degree
  • Length: 200 Millimeter
  • Bite Size 3mm
S127

  • Bone-coring punch, single-use

Single Use Professional - 05055299102190

Kerrison Rongeur 2mm x 200mm 45° contains 6 units
EAKIN SURGICAL LIMITED
S126
In Commercial Distribution

  • 05055299102190 ()

  • Angle: 45 degree
  • Length: 200 Millimeter
  • Bite Size 2mm
S126

  • Bone-coring punch, single-use

Single Use Professional - 05055299102176

Kerrison Rongeur 1mm x 200mm 45°contains 6 units
EAKIN SURGICAL LIMITED
S125
In Commercial Distribution

  • 05055299102176 ()

  • Length: 200 Millimeter
  • Angle: 45 degree
  • Bite Size 1mm
S125

  • Bone-coring punch, single-use

BLOOD GAS CONTROL - LEVEL 3 (BG CONTROL 3) - 05055273227123

No Description
RANDOX LABORATORIES LIMITED
BG5003
In Commercial Distribution

  • 05055273227123 ()
BG5003

  • Multiple blood gas analyte IVD, control

BLOOD GAS CONTROL - LEVEL 2 (BG CONTROL 2) - 05055273227116

No Description
RANDOX LABORATORIES LIMITED
BG5002
In Commercial Distribution

  • 05055273227116 ()
BG5002

  • Multiple blood gas analyte IVD, control

BLOOD GAS CONTROL - LEVEL 1 (BG CONTROL 1) - 05055273227109

No Description
RANDOX LABORATORIES LIMITED
BG5001
In Commercial Distribution

  • 05055273227109 ()
BG5001

  • Multiple blood gas analyte IVD, control

CARDIAC CONTROL - LEVEL 1 (CRD CONTROL 1) - 05055273217650

This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10429
In Commercial Distribution

  • 05055273217650 ()
CQ10429

  • Multiple cardiac marker IVD, control

MATERNAL CONTROL - LEVEL 3 (MATERNAL CONTROL 3) - 05055273217599

This product is intended for in vitro use in the quality control of Alpha-fetoprotein, Free Beta HCG, Free Estriol, Human Chorionic Gonadotrophin, Inhibin A and PAPP-A methods on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
MSS5026
In Commercial Distribution

  • 05055273217599 ()
MSS5026

  • Trisomy 21-risk hormone IVD, control

MATERNAL CONTROL - LEVEL 2 (MATERNAL CONTROL 2) - 05055273217582

This product is intended for in vitro use in the quality control of Alpha-fetoprotein, Free Beta HCG, Free Estriol, Human Chorionic Gonadotrophin, Inhibin A and PAPP-A methods on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
MSS5025
In Commercial Distribution

  • 05055273217582 ()
MSS5025

  • Trisomy 21-risk hormone IVD, control

MATERNAL CONTROL - LEVEL 1 (MATERNAL CONTROL 1) - 05055273217575

This product is intended for in vitro use, in the quality control of Alpha-fetoprotein, Free Beta hCG, Free Estriol, Human Chorionic Gonadotropin, Inhibin A and PAPP-A methods on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
MSS5024
In Commercial Distribution

  • 05055273217575 ()
MSS5024

  • Trisomy 21-risk hormone IVD, control

CARDIAC ULTRA LOW CONTROL (CRD CONTROL Ultra Low) - 05055273217346

This product is intended for intended for use with in vitro diagnostic assays, for the quantitative determination of Troponin I. Cardiac Controls are unassayed without target values and are suitable for use on automated analysers. Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
CQ10428
In Commercial Distribution

  • 05055273217346 ()
CQ10428

  • Multiple cardiac marker IVD, control

APOLIPOPROTEIN CALIBRATOR 2 (APO CAL 2) - 05055273209204

No Description
RANDOX LABORATORIES LIMITED
LP5047
In Commercial Distribution

  • 05055273209204 ()


  • Multiple apolipoprotein IVD, calibrator

APOLIPOPROTEIN CONTROL - LEVEL 3 (APO CONTROL 3) - 05055273209129

No Description
RANDOX LABORATORIES LIMITED
LE5018
In Commercial Distribution

  • 05055273209129 ()


  • Multiple apolipoprotein IVD, control

APOLIPOPROTEIN CONTROL - LEVEL 2 (APO CONTROL 2) - 05055273209112

No Description
RANDOX LABORATORIES LIMITED
LE5017
In Commercial Distribution

  • 05055273209112 ()


  • Multiple apolipoprotein IVD, control

APOLIPOPROTEIN CONTROL - LEVEL 1 (APO CONTROL 1) - 05055273209105

No Description
RANDOX LABORATORIES LIMITED
LE5016
In Commercial Distribution

  • 05055273209105 ()


  • Multiple apolipoprotein IVD, control

AST - 05055273208245

The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotransferase (AST) in serum or plasma.
RANDOX LABORATORIES LIMITED
AS8306
In Commercial Distribution

  • 05055273208245 ()
AS8306

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent

ALKALINE PHOSPHATASE (ALP) - 05055273208207

No Description
RANDOX LABORATORIES LIMITED
AP8302
In Commercial Distribution

  • 05055273208207 ()


  • Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry

EDDP - 05055273208061

The EDDP assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in human urine.
RANDOX LABORATORIES LIMITED
DA4013
In Commercial Distribution

  • 05055273208061 ()
DA4013

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, reagent

BENZ CONTROL 2 - 05055273207996

The Randox Benzodiazepines Control Level 2 is intended for use in the Quality Control of the Benzodiazepines (BENZ) assay. The Benzodiazepine Control Level 2 contains the specific drug Oxazepam.
RANDOX LABORATORIES LIMITED
DA3131
In Commercial Distribution

  • 05055273207996 ()
DA3131

  • Benzodiazepine group IVD, control

BENZ CAL - 05055273207972

The Randox Benzodiazepines Calibrator Set is intended for use in the calibration of the Benzodiazepines assay. The Calibrator Set contains 5 levels of calibrator containing the specific drug Oxazepam.
RANDOX LABORATORIES LIMITED
DA3129
In Commercial Distribution

  • 05055273207972 ()
DA3129

  • Benzodiazepine group IVD, calibrator

EDDP CONTROL 1 - 05055273207910

The Randox EDDP Control - Level 1 is intended for use in the Quality Control of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. The EDDP Control - Level 1 contains the specific drug EDDP.
RANDOX LABORATORIES LIMITED
DA3123
In Commercial Distribution

  • 05055273207910 ()
DA3123

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control

DOA CONTROL 2 - 05055273207903

The Randox Multidrug Control Level 2 is intended for use in the Quality Control of Methamphetamine, Barbiturates, Cocaine, Methadone and Opiates assays.
RANDOX LABORATORIES LIMITED
DA3122
In Commercial Distribution

  • 05055273207903 ()
DA3122

  • Multiple drugs of abuse IVD, control

DOA CAL - 05055273207880

The Randox Multidrug Calibrator Set is intended for use in the calibration of Methamphetamine, Barbiturates, Cocaine Metabolite, Methadone and Opiate assays.
RANDOX LABORATORIES LIMITED
DA2704
In Commercial Distribution

  • 05055273207880 ()
DA2704

  • Multiple drugs of abuse IVD, calibrator

EDDP CAL - 05055273207866

The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay.
RANDOX LABORATORIES LIMITED
DA2702
In Commercial Distribution

  • 05055273207866 ()
DA2702

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator

RX daytona plus - 05055273207774

The Randox RX daytona plus with ISE is a fully automated, random access, clinical chemistry analyser complete with dedicated analyser software.
RANDOX LABORATORIES LIMITED
RX4040
In Commercial Distribution

  • 05055273207774 ()
RX4040

  • Multiple clinical chemistry analyser IVD, laboratory

COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3) - 05055273207644

No Description
RANDOX LABORATORIES LIMITED
CG5023
In Commercial Distribution

  • 05055273207644 ()


  • Multiple coagulation factor IVD, control

COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2) - 05055273207637

No Description
RANDOX LABORATORIES LIMITED
CG5022
In Commercial Distribution

  • 05055273207637 ()


  • Multiple coagulation factor IVD, control

CARDINAL HEALTH - 10888439957327

HORMONE PELLET TRAY
Cardinal Health 200, LLC
09-7774A
In Commercial Distribution

  • 50888439957325 ()
  • 10888439957327 ()
09-7774A

  • General surgical procedure kit, medicated

TARGETER ALIGNMENT LOCK - 00848665035667

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
4919-000
In Commercial Distribution

  • 00848665035667 ()


  • Orthopaedic fixation implant alignment tool
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