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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Lead Locking Device (LLD EZ)
Spectranetics Corporation
518-062
Not in Commercial Distribution

  • M2045180621 ()
  • M2045180620 ()
518-062

  • Pacing/defibrillation lead stylet
Turbo-Booster™ Laser Guide Catheter
Spectranetics Corporation
518-043
Not in Commercial Distribution

  • M2045180431 ()
  • M2045180430 ()

  • Lumen/Inner Diameter: 0.094 Inch
518-043

  • Vascular guide-catheter, single-use
Lead Locking Device (LLD E)
Spectranetics Corporation
518-039
Not in Commercial Distribution

  • M2045180391 ()
  • M2045180390 ()
518-039

  • Pacing/defibrillation lead stylet
Quick-Cross™ Support Catheter
Spectranetics Corporation
518-038
Not in Commercial Distribution

  • M2045180381 ()
  • M2045180380 ()

  • Length: 150 Centimeter
518-038

  • Vascular guide-catheter, single-use
Quick-Cross™ Support Catheter
Spectranetics Corporation
518-037
Not in Commercial Distribution

  • M2045180371 ()
  • M2045180370 ()

  • Length: 135 Centimeter
518-037

  • Vascular guide-catheter, single-use
Quick-Cross™ Support Catheter
Spectranetics Corporation
518-036
Not in Commercial Distribution

  • M2045180361 ()
  • M2045180360 ()

  • Length: 90 Centimeter
518-036

  • Vascular guide-catheter, single-use
Quick-Cross™ Support Catheter
Spectranetics Corporation
518-035
Not in Commercial Distribution

  • M2045180351 ()
  • M2045180350 ()

  • Height: 150 Centimeter
518-035

  • Vascular guide-catheter, single-use
Quick-Cross™ Support Catheter
Spectranetics Corporation
518-034
Not in Commercial Distribution

  • M2045180341 ()
  • M2045180340 ()

  • Length: 135 Centimeter
518-034

  • Vascular guide-catheter, single-use
Quick-Cross™ Support Catheter
Spectranetics Corporation
518-033
Not in Commercial Distribution

  • M2045180331 ()
  • M2045180330 ()

  • Length: 90 Centimeter
518-033

  • Vascular guide-catheter, single-use
Quick-Cross™ Support Catheter
Spectranetics Corporation
518-032
Not in Commercial Distribution

  • M2045180321 ()
  • M2045180320 ()

  • Length: 135 Centimeter
518-032

  • Vascular guide-catheter, single-use
Lead Locking Device (LLD #3)
Spectranetics Corporation
518-020
Not in Commercial Distribution

  • M2045180201 ()
  • M2045180200 ()
518-020

  • Pacing/defibrillation lead stylet
Lead Locking Device (LLD #2)
Spectranetics Corporation
518-019
Not in Commercial Distribution

  • M2045180191 ()
  • M2045180190 ()
518-019

  • Pacing/defibrillation lead stylet
Lead Locking Device (LLD #1)
Spectranetics Corporation
518-018
Not in Commercial Distribution

  • M2045180181 ()
  • M2045180180 ()
518-018

  • Pacing/defibrillation lead stylet
TorqMax™ Sheath Grip Assembly
Spectranetics Corporation
502-001
Not in Commercial Distribution

  • M2045020011 ()
  • M2045020010 ()

  • Outer Diameter: 7.5 Millimeter
502-001

  • Torque manipulation device
MARTIN LEWIS G.C. SYSTEM
Healthlink
V800
In Commercial Distribution

  • M202V8002 ()
  • M202V8001 ()
  • M202V8000 ()

  • 100 mm
  • Outer Diameter: 100 Millimeter
V800

  • Neiserria species agar culture medium IVD, basic
MARTIN LEWIS G.C. SYSTEM
Healthlink
7-657-ML
In Commercial Distribution

  • M2027657ML3 ()
  • M2027657ML2 ()
  • M2027657ML0 ()

  • Outer Diameter: 100 Millimeter
  • 100 mm
7-657-ML

  • Neiserria species agar culture medium IVD, basic
BOWIE-DICK TYPE TEST PACK pkg of 20 tests
Healthlink
3980
In Commercial Distribution

  • M202398023 ()
  • M202398012 ()
  • M202398001 ()
3980

  • Chemical/physical sterilization process indicator
JEMBEC MOD THAYER MARTIN
Healthlink
1738
In Commercial Distribution

  • M20217382 ()
  • M202173811 ()
  • M20217380 ()

  • 100 mm
  • Outer Diameter: 100 Millimeter
1738

  • Thayer-Martin Neisseria species agar culture medium IVD
JEMBEC MARTIN LEWIS
Healthlink
1737
In Commercial Distribution

  • M20217372 ()
  • M20217371 ()
  • M20217370 ()

  • Outer Diameter: 100 Millimeter
  • 100 mm
1737

  • Neiserria species agar culture medium IVD, basic
Bullseye Urine
Healthlink
1502
In Commercial Distribution

  • M20215022 ()
  • M20215021 ()
  • M20215020 ()

  • Outer Diameter: 100 Millimeter
  • 100 mm
1502

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD
MUELLER HINTON w 5% SB
Healthlink
1107
In Commercial Distribution

  • M20211072 ()
  • M20211071 ()
  • M20211070 ()

  • Outer Diameter: 150 Millimeter
  • 150 mm
1107

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD, sheep blood
MUELLER HINTON
Healthlink
1106
In Commercial Distribution

  • M20211062 ()
  • M20211061 ()
  • M20211060 ()

  • Outer Diameter: 100 Millimeter
  • 100 mm
1106

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD
MUELLER HINTON w 5% SB
Healthlink
1104
In Commercial Distribution

  • M20211042 ()
  • M20211041 ()
  • M20211040 ()

  • 100 mm
  • Outer Diameter: 100 Millimeter
1104

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD, sheep blood
MUELLER HINTON
Healthlink
1103
In Commercial Distribution

  • M20211032 ()
  • M20211031 ()
  • M20211030 ()

  • 100 mm
  • Outer Diameter: 100 Millimeter
1103

  • Mueller-Hinton agar antimicrobial susceptibility culture medium IVD
MODIFIED THAYER MARTIN
Healthlink
1100
In Commercial Distribution

  • M20211002 ()
  • M20211001 ()
  • M20211000 ()

  • 100 mm
  • Outer Diameter: 100 Millimeter
1100

  • Thayer-Martin Neisseria species agar culture medium IVD
MARTIN LEWIS AGAR
Healthlink
1095
In Commercial Distribution

  • M20210952 ()
  • M20210951 ()
  • M20210950 ()

  • Outer Diameter: 100 Millimeter
  • 100 mm
1095

  • Neiserria species agar culture medium IVD, basic
The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.
SERIM RESEARCH CORPORATION
05140S
In Commercial Distribution

  • M1745140S2 ()
  • M1745140S1 ()
  • M1745140S0 ()
05140S

  • Helicobacter pylori urease IVD, kit, chromogenic
Serim DISINTEK GTA 1.5% Test Strips are used to determine whether the glutaraldehyde concentration is above or at/below the Minimum Effective Concentration (MEC) of 1.5% for CIDEX® or MetriCide® reusable glutaraldehyde high-level disinfectants.
SERIM RESEARCH CORPORATION
5136A
In Commercial Distribution

  • M1745136A1 ()
  • M1745136A0 ()
  • M1745136A2 ()
5136A

  • Glutaraldehyde device disinfectant/sterilant test strip
Serim® DISINTEK™ OPA Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in CIDEX® OPA Solution and MetriCide® OPA Plus™ Solution, is above or below the established minimum effective concentration (MEC) of 0.3%.
SERIM RESEARCH CORPORATION
5121
In Commercial Distribution

  • M17451212 ()
  • M17451211 ()
  • M17451210 ()
5121

  • Ortho-phthalaldehyde (OPA) device disinfectant test strip
Serim® GUARDIAN™ BICARB pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems.
SERIM RESEARCH CORPORATION
5116B
Not in Commercial Distribution

  • M1745116B2 ()
  • M1745116B1 ()
  • M1745116B0 ()
5116B

  • Multi-parameter device tester
Serim® GUARDIAN™ Bicarb pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems.
SERIM RESEARCH CORPORATION
5116A
In Commercial Distribution

  • M1745116A1 ()
  • M1745116A2 ()
  • M1745116A0 ()
5116A

  • Multi-parameter device tester
The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate.
SERIM RESEARCH CORPORATION
5109
In Commercial Distribution

  • M17451092 ()
  • M17451091 ()
  • M17451090 ()
5109

  • Multi-parameter device tester
SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency) of peracetic acid in dialyzer reprocessing concentrates such as Renalin® Cold Sterilant, PerAldecide™, Puristeril® 340, Peracidin™ and Micro-X®.
SERIM RESEARCH CORPORATION
5106
In Commercial Distribution

  • M17451061 ()
  • M17451060 ()
  • M17451062 ()
5106

  • Medical device disinfection solution test strip
Serim® GUARDIAN™ Residual Peroxide Test Strips measure the concentration of peroxide remaining in dialysate lines and dialyzers after disinfection with peracetic acid/peroxide-based disinfectants.
SERIM RESEARCH CORPORATION
5105
In Commercial Distribution

  • M17451052 ()
  • M17451051 ()
  • M17451050 ()
5105

  • Multi-parameter device tester
Serim® GUARDIAN™ Residual Chlorine Test Strips indicating the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.
SERIM RESEARCH CORPORATION
5100C
In Commercial Distribution

  • M1745100C2 ()
  • M1745100C1 ()
  • M1745100C0 ()
5100C

  • Multi-parameter device tester
Serim® GUARDIAN™ RESIDUAL CHLORINE Test Strips indicate the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.
SERIM RESEARCH CORPORATION
5100A
In Commercial Distribution

  • M1745100A1 ()
  • M1745100A0 ()
  • M1745100A2 ()
5100A

  • Multi-parameter device tester
Ocular irrigation system
Mortan Inc.
MT6673
In Commercial Distribution

  • M170MT66731 ()
  • M170MT66730 ()


  • Eye irrigation shield, single-use
Ocular irrigation system
Mortan Inc.
MT2000
In Commercial Distribution

  • M170MT20000 ()
  • M170MT20001 ()


  • Eye irrigation shield, single-use
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-22
In Commercial Distribution

  • M09107RD7065221 ()
  • M09107RD7065220 ()

  • Length: 75 Millimeter
07RD7065-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PASV MS Kit with Pressure Activated Safety Valve with 6.5F x 5cm Dilator
NAVILYST MEDICAL, INC.
MS6K
In Commercial Distribution

  • M001MS6K1 ()
  • M001MS6K0 ()

  • Catheter Gauge: 6.5 French
  • Length: 5 Centimeter
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable
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