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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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HarmonyAIR - 00724995191573

The M5 High Density Dual Package, Single Flat Panel Monitor Mount, without/Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191573 ()
LMH02T

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995191566

The M5 High Density Dual Package, Single Flat Panel Monitor Mount, No Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191566 ()
LMH02

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995191528

The M5 High Density Single Package with Hub Spacer, Single Flat Panel Monitor Mount is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191528 ()
LMH24

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995191511

The M5 High Density Single Package No Hub, Single Flat Panel Monitor Mount, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191511 ()
LMH04T

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995191504

The M5 High Density Single Package No Hub Spacer, Single Flat Panel Monitor Mount is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191504 ()
LMH04

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light

HarmonyAIR - 00724995191450

The M5, Dual Package with two Single Flat Panel Monitor Mount, No Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191450 ()
LM03

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995191443

The M5, Dual Package with Single Flat Panel Monitor Mount, without/Hub Spacer, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191443 ()
LM02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995190491

The M7 Single High Density Package with Hub Spacer, Single Flat Panel Monitor, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995190491 ()
LMH29NT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995190484

The M7 SGL High Density Package with Hub Spacer and Single Flat Panel Monitor is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995190484 ()
LMH29N

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995190477

The M7 Single Package with Single High Density Flat Panel Monitor with Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995190477 ()
LM29NT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995168360

The HarmonyAIR E-Series Dual Light, Single Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168360 ()
LES02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995167370

The G5 Single Light Camera with ConnectPoint Express, Single Flat Panel Monitor and Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995167370 ()
P056939299

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995167158

The G5 Dual Light with Camera, No Camera Single Flat Panel Monitor with Tandem is used with the HarmonyAIR G-Series Lighting System.
STERIS CORPORATION
G-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995167158 ()
LGH12NT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995169589

The Dual Spindle Dual Flat Panel Monitor CRT Light Head with Video 11008896 G-Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995169589 ()
LGH00039

  • Medical monitor/light mount

HarmonyAIR - 00724995168643

The HarmonyAIR E-Series Single Light, Dual Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168643 ()
LES13

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system

HarmonyAIR - 00724995168636

E-Series High Definition Single Light, Dual Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168636 ()
LEH13

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995168629

The HarmonyAIR E-Series Single Light Dual Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168629 ()
LES11

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995168353

The HarmonyAIR E-Series DL LT , Single Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995168353 ()
LEH02

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light

HarmonyAIR - 00724995166588

The Single High Density M5, No Control with Single Flat Panel Monitor, Spring Arm is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995166588 ()
LMH24N

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

HarmonyAIR - 00724995165680

The Single M5 without Control with Single Flat Panel Monitor, Spring Arm and Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165680 ()
LM24NT

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995165659

The Single M5 without Control with Single M5 with Single Flat Panel Monitor, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165659 ()
LM04NT

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount

T2Candida® 1.1 Cartridge Kit - M70890078170

The T2Candida 1.1 Cartridge components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
90-07817
In Commercial Distribution

  • M70890078170 ()


  • Multiple Candida species nucleic acid IVD, reagent

CRL STAT Cup - 00817815020877

CRL STAT 11 Panel Cup- KCUR920082 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920082
In Commercial Distribution

  • 00817815020877 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

X-MIND trium - D804W09002300

X-MIND trium PAN CEPH version including one removable ceph sensor, with control panel on the right and ceph arm on the right
DE GÖTZEN SRL
XMT PAN R CEPH R
Not in Commercial Distribution

  • D804W09002300 ()
W0900230

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck

X-MIND trium - D804W09002260

X-MIND trium PAN T version including one removable pan sensor with control panel on the left configurated for installation of CBCT sensor
DE GÖTZEN SRL
XMT PAN 3D READY L
Not in Commercial Distribution

  • D804W09002260 ()
W0900226

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital

X-MIND trium - D804W09002250

X-MIND trium PAN T version including one removable pan sensor with control panel on the right configurated for installation of CBCT sensor
DE GÖTZEN SRL
XMT PAN 3D READY R
Not in Commercial Distribution

  • D804W09002250 ()
W0900225

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck

X-MIND trium - D804W09000030

X-MIND trium PAN CEPH version including one removable ceph sensor, with control panel on the right and ceph arm on the left
DE GÖTZEN SRL
XMT PAN R CEPH L
Not in Commercial Distribution

  • D804W09000030 ()
W0900003

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck

SkyVision - 10841736111724

SkyVision LINX 300 Digital Integration system includes: Medical Grade Touch Panel, Optical Router, IP addressable Control Switch and On-Board Uninterruptable Power Supply.
SKYTRON LLC
LINX 300
In Commercial Distribution

  • 10841736111724 ()
SVIS-LINX

  • Radiology picture archiving and communication system digital archive device

Identify Health - 10850013035028

13 Panel CLIA Waived Cup - Identify Health AMP500, BAR300, BUP10, BZO300, COC150, MTD300, MDMA500, MET500, OPI300, OXY100, PCP25, TCA1000, THC50 3mm Strip
MEDICAL DISTRIBUTION GROUP INC
ID-H13-1
In Commercial Distribution

  • 10850013035028 ()
  • 00850721007105 ()
ID-H13-1

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Identify Diagnostics USA - 10850721007942

(Identify USA - Drug Test Cups) / 6 Panel CLIA Waived Cup - AMP500, BZO300, COC150, MOR/OPI300, OXY100, THC50 3mm Strip - 25 Pack Box
MEDICAL DISTRIBUTION GROUP INC
ID-US6
In Commercial Distribution

  • 20850721007949 ()
  • 10850721007942 ()
  • 00850721007945 ()
ID-US6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

UCP Home Drug Screening Test Cups - 10817038021627

UCP Home Drug Screening Test Cups 10 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/PCP/AMP
UCP BIOSCIENCES, INC.
U-CUP-6104-RCN
In Commercial Distribution

  • 20817038021624 ()
  • 10817038021627 ()
  • 00817038021620 ()
U-CUP-6104-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

u-Card Drug Test Screen - 10817038021368

12 panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC with Adulteration strip(S.G./CRE/ pH)
UCP BIOSCIENCES, INC.
U-DUD-6124L
In Commercial Distribution

  • 20817038021365 ()
  • 10817038021368 ()
  • 00817038021361 ()
U-DUD-6124L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

iCup® - 10817405021342

iCup® E&I Urine Test 6 Panel Drug Screen Cup w/SVT (CR/pH/SG) (AMP1000/COC300/MET1000/OPI2000/OXY100/PCP25)
Instant Technologies, Inc.
DPG-167-1202
In Commercial Distribution

  • 00817405021345 ()
  • 10817405021342 ()
DPG-167-1202

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

u-Cup Drug Test Screen - 10817038021184

12 Panel Drug Test Cup W/AD AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC(S.G., CRE,pH)
UCP BIOSCIENCES, INC.
U-DUD-6124
In Commercial Distribution

  • 20817038021181 ()
  • 10817038021184 ()
  • 00817038021187 ()
U-DUD-6124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

u-Cup Drug Test Screen - 10817038021108

12 Panel Drug Test Cup W/AD AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC)(S.G., CRE,pH)
UCP BIOSCIENCES, INC.
U-DUD-20124
In Commercial Distribution

  • 20817038021105 ()
  • 10817038021108 ()
  • 00817038021101 ()
U-DUD-20124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response 6 Panel Saliva Test Cup E/I Screening - 10722066006808

Rapid Response 6 Panel Saliva Test Cup E/I Screening (D6.64-2FC1E)- AMP50, COC20, MET50, OPI40, OXY20, PCP10. For employment and insurance testing.
BTNX Inc
D6.64-2FC1E
In Commercial Distribution

  • 00722066006801 ()
  • 10722066006808 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response 6 Panel Saliva Test Cup E/I Screening - 10722066006792

Rapid Response 6 Panel Saliva Test Cup E/I Screening (D6.61-2FC1E)- AMP50, COC20, BAR50, OPI40, PCP10, THC40. For employment and insurance testing.
BTNX Inc
D6.61-2FC1E
In Commercial Distribution

  • 00722066006795 ()
  • 10722066006792 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response 6 Panel Saliva Test Cup E/I Screening - 10722066006785

Rapid Response 6 Panel Saliva Test Cup E/I Screening (D6.3.1-2FC1E)- AMP50, COC20, MET50, OPI40, PCP10, THC40. For employment and insurance testing.
BTNX Inc
D6.3.1-2FC1E
In Commercial Distribution

  • 00722066006788 ()
  • 10722066006785 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Rapid Response - 10722066005672

One Step 12 Panel DOA Cup (12.5.1) - AMP500 BAR300 BUP10 BZO300 COC150 MDMA500 MTD300 MET500 MOP2000 OXY100 THC50 PCP25 pH/CRE/SG.
BTNX Inc
D12.5.1-1VA
In Commercial Distribution

  • 00722066005675 ()
  • 10722066005672 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

ImmuTest Drugs of Abuse Cup - 00816565020359

10 panel test cup, (BZO/BAR)+(OXY/MDMA)+(PCP/AMP)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-10M5
Not in Commercial Distribution

  • 00816565020359 ()
IMCA-10M5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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