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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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Alkaline phosphatase liquid acc to IFCC - 04015630916443

No Description
Roche Diagnostics GmbH
12173174122
In Commercial Distribution

  • 04015630916443 ()
12173174122

  • Total alkaline phosphatase (ALP) IVD, reagent

Alkaline phosphatase liquid acc to IFCC - 04015630916436

No Description
Roche Diagnostics GmbH
12173158122
In Commercial Distribution

  • 04015630916436 ()
12173158122

  • Total alkaline phosphatase (ALP) IVD, reagent

Alkaline phosphatase liquid acc to IFCC - 04015630916429

No Description
Roche Diagnostics GmbH
12173107122
In Commercial Distribution

  • 04015630916429 ()
12173107122

  • Total alkaline phosphatase (ALP) IVD, reagent

Lactate dehydrogenase liquid acc to IFCC - 04015630916337

No Description
Roche Diagnostics GmbH
3002209122
In Commercial Distribution

  • 04015630916337 ()
3002209122

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry

Lactate Dehydrogenase acc to IFCC ver2 - 04015630916276

No Description
Roche Diagnostics GmbH
3004732122
In Commercial Distribution

  • 04015630916276 ()
3004732122

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry

Creatine Kinase liquid, acc. to IFCC - 04015630912889

No Description
Roche Diagnostics GmbH
12132672216
In Commercial Distribution

  • 04015630912889 ()
12132672216

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

AcuPulse Upgrade Kit 40 to 40AES-F - 07290117771549

No Description
LUMENIS BE LTD
NA
In Commercial Distribution

  • 07290117771549 ()


  • General/multiple surgical carbon dioxide laser system

AcuPulse Upgrade Kit 40 to 40AES-R - 07290117771532

No Description
LUMENIS BE LTD
NA
In Commercial Distribution

  • 07290117771532 ()


  • General/multiple surgical carbon dioxide laser system

AcuPulse Upgrade Kit 40AES-F to 40AES-R - 07290117771525

No Description
LUMENIS BE LTD
NA
In Commercial Distribution

  • 07290117771525 ()


  • General/multiple surgical carbon dioxide laser system

QC Adapter, Quarter Inch to POWEREASE - 00810055521968

QC Adapter, Quarter Inch to POWEREASE
Si-Bone Inc.
501485
In Commercial Distribution

  • 00810055521968 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

LEAD WIRE, PINCH TO INTELLIVUE, INTERMED - 90840828100949

LEAD WIRE, PINCH TO INTELLIVUE, INTERMED
CURBELL MEDICAL PRODUCTS, INC.
DLW-05BK-40AS-3000
Not in Commercial Distribution

  • 90840828101090 ()
  • 90840828100949 ()
18592

  • Electrocardiographic electrode, single-use

LEAD WIRE, SNAP TO NIHON KONDEN - 90840828101526

LEAD WIRE, SNAP TO NIHON KONDEN
CURBELL MEDICAL PRODUCTS, INC.
DLW-06AF-MXAN-0000
In Commercial Distribution

  • 90840828101540 ()
  • 90840828101526 ()
  • 90840828101533 ()
19778

  • Electrocardiographic electrode, single-use

Desk to Full Armrest Extension Kit - 07540147002893

Desk to Full Armrest Extension Kit. Armrest Extension tube (insert) to allow longer tube lengths for mounting full length arm pads or to allow for greater arm pad depth adjustment. Mounting hardware included. Kit contains one extension tube
Motion Concepts Inc
D-0123-0128-AEXT
In Commercial Distribution

  • 07540147002893 ()
AEXT

  • Wheelchair armrest

BRAEBON Q-RIP to Belt Controller Cable - B14005730

Cable for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Braebon Medical Corporation
0573
In Commercial Distribution

  • B14005730 ()
0573

  • Electrical-only medical device connection cable, reusable

Cable, V1-MPC to Electrode – Zoll (~10ft) - 00811331018332

Cable, V1-MPC to Electrode – Zoll (~10ft)
Tz Medical, Inc.
PAD 6090
In Commercial Distribution

  • 00811331018332 ()


  • Electrical catheter connection cable/switch

Retainer - 3 to 3 no mesh - 00810126380067

No Description
Digital Dental Laboratories, Inc
0067
In Commercial Distribution

  • 00810126380067 ()


  • Orthodontic retainer

#LubeLife – Trying to Conceive (TTC) – 2oz - 00796494001639

Fertility-Friendly Personal Lubricant
CC Wellness LLC
42013
In Commercial Distribution

  • 10796494001636 ()
  • 00796494001639 ()


  • Sexual lubricant

12" COMFOR ABD BINDER-UP TO 45" - 50610570002554

No Description
Bird & Cronin, LLC
08140445
In Commercial Distribution

  • 50610570002554 ()
  • 00610570002559 ()


  • Abdominal binder, single-use

Power Supply to remote USB cable - 37630039300594

No Description
Bracco Injeneering SA
017527
In Commercial Distribution

  • 37630039300594 ()
017527

  • CT contrast medium injection system, line-powered, stationary

LEAD WIRE, PINCH TO NIHON KONDEN - 90840828100192

LEAD WIRE, PINCH TO NIHON KONDEN
CURBELL MEDICAL PRODUCTS, INC.
DLW-06BF-MXAN-0000
In Commercial Distribution

  • 90840828100208 ()
  • 90840828100192 ()
  • 90840828100215 ()
6769

  • Electrocardiographic electrode, single-use

VISION PIN TO BAR FIXATION SYSTEM - 00888480189312

No Description
Biomet Orthopedics, LLC
14660
In Commercial Distribution

  • 00888480189312 ()

  • 9.5MM Ø 600MM LENGTH
14660

  • External orthopaedic fixation system, single-use

Guarded Luer Connector Female to Male - B212574011

Guarded Luer Connector Female to Male, Yellow, Sterile, Box of 50 individual blisters.
INTERNATIONAL MEDICAL INDUSTRIES INC.
57-401
In Commercial Distribution

  • B212574012 ()
  • B212574011 ()
  • B212574010 ()
57-401

  • Luer/Luer linear connector, single-use

Guarded Luer Connector Female to Female - B21257400W1

Guarded Luer Connector Female to Female, White, Sterile, Box of 50 individual blisters.
INTERNATIONAL MEDICAL INDUSTRIES INC.
57-400W
In Commercial Distribution

  • B21257400W1 ()
  • B21257400W2 ()
57-400W

  • Luer/Luer linear connector, single-use

Guarded Luer Connector Female to Female - B212574001

Guarded Luer Connector Female to Female, Red, Sterile, Box of 50 individual blisters.
INTERNATIONAL MEDICAL INDUSTRIES INC.
57-400
In Commercial Distribution

  • B212574002 ()
  • B212574001 ()
  • B212574000 ()
57-400

  • Luer/Luer linear connector, single-use

Surgical Manual Instrument - 07630542776168

GMK Sphere Fem 2 to 7R Tib 2 to 6R Ins 2 to 6R
Medacta International SA
02.12.10.8572
In Commercial Distribution

  • 07630542776168 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Surgical Manual Instrument - 07630542776151

GMK Sphere Fem 2 to 7L Tib 2 to 6L Ins 2 to 6L
Medacta International SA
02.12.10.8571
In Commercial Distribution

  • 07630542776151 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Surgical Manual Instrument - 07630542776113

GMK SpheriKA Fem 2 to 7R Tib 2 to 6R Ins 2 to 6R
Medacta International SA
02.12.10.8567
In Commercial Distribution

  • 07630542776113 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Surgical Manual Instrument - 07630542776106

GMK SpheriKA Fem 2 to 7L Tib 2 to 6L Ins 2 to 6L
Medacta International SA
02.12.10.8566
In Commercial Distribution

  • 07630542776106 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

APOZA - 04719883751362

Light Guide 8mm to 2mm. Accessories for APOZA LED Light Curing Unit
APOZA ENTERPRISE CO., LTD.
LIGHT GUIDE-8mm to 2mm
In Commercial Distribution

  • 04719883751362 ()

  • Outer Diameter: 2 Millimeter


  • Dental/surgical polymerization lamp

MR 5300, MR 7700 & Ingenia - 00884838108653

Upgrades dStream to R11
Philips Medical Systems Nederland B.V.
Upgrades dStream to R11
In Commercial Distribution

  • 00884838108653 ()
782142

  • Full-body MRI system, superconducting magnet

Ingenia, MR 5300 - 00884838101135

R5.7 brings software and application improvements. These include SmartExam enhancements with Quick Smart Survey. Other SW enhancements are including Prescan Redesign, Automated Analysis Software to generate data for American College of Radiology (ACR) Accreditation etc. R5.7 is also enabler for optional new clinical features like 4D FreeBreathing, MR Elastography Extension, MultiBand SENSE with dS Head coil and in 1.5T & Diffusion Excellence Pack
Philips Medical Systems Nederland B.V.
Upgrades dStream to R5.7
In Commercial Distribution

  • 00884838101135 ()
782111

  • Full-body MRI system, superconducting magnet

Ingenia, MR 5300 and MR 7700 - 00884838128507

Upgrades dStream to R12.3
Philips Medical Systems Nederland B.V.
Upgrades dStream to R12.3
In Commercial Distribution

  • 00884838128507 ()
782200

  • Full-body MRI system, superconducting magnet

MR 7700 - 00884838122239

Upgrade to workflow, and gradient performance of the MR 7700 for Ingenia 3.0T customers.
Philips Medical Systems Nederland B.V.
SmartPath to MR 7700
In Commercial Distribution

  • 00884838122239 ()
782178

  • Full-body MRI system, superconducting magnet

MR 7700 - 00884838115781

Upgrade to the MR 7700 gradient performance for customers having an Elition X
Philips Medical Systems Nederland B.V.
Upgrade to MR 7700
In Commercial Distribution

  • 00884838115781 ()
782167

  • Full-body MRI system, superconducting magnet

Ingenia, MR 5300, MR 7700, Achieva - 00884838115729

Upgrades dStream to R12
Philips Medical Systems Nederland B.V.
Upgrades dStream to R12
In Commercial Distribution

  • 00884838115729 ()
782161

  • Full-body MRI system, superconducting magnet

GN Otometrics A/S - 05713315004599

No Description
Natus Medical Denmark ApS
"TO/TB monitoring system
In Commercial Distribution

  • 05713315004599 ()


  • Tone audiometer, semi-automated

GN Otometrics A/S - 05713315004582

No Description
Natus Medical Denmark ApS
"TO/TB monitoring system
In Commercial Distribution

  • 05713315004582 ()


  • Tone audiometer, semi-automated

GN Otometrics A/S - 05713315000683

No Description
Natus Medical Denmark ApS
TO/TB Sound Tube
Not in Commercial Distribution

  • 05713315000683 ()


  • Tone audiometer, semi-automated

Voluson - 00195278560124

Voluson SWIFT to BT23 UPG
GE Ultrasound Korea Ltd.
SWIFT to BT23 UPG
In Commercial Distribution

  • 00195278560124 ()
5919153

  • General-purpose ultrasound imaging system

Voluson - 00195278473028

Voluson Signature to BT22 UPG
GE Ultrasound Korea Ltd.
Signature to BT22 UPG
In Commercial Distribution

  • 00195278473028 ()
Voluson-Signature-to-BT22-UPG

  • General-purpose ultrasound imaging system

Voluson - 00195278677587

Voluson Exp to BT24 UPG
GE Healthcare Austria GmbH & Co OG
Exp to BT24 UPG
In Commercial Distribution

  • 00195278677587 ()
5936797

  • General-purpose ultrasound imaging system

Voluson - 00195278473011

Voluson Performance to BT22 UPG
GE Ultrasound Korea Ltd.
Performance to BT22 UPG
In Commercial Distribution

  • 00195278473011 ()
Voluson-Performance-to-BT22-UPG

  • General-purpose ultrasound imaging system

Flexport - 10841522106392

FLEXPORT 2,MAQUET FLOW-I,91443B
SPACELABS HEALTHCARE (WASHINGTON), INC
Flexport2 to Drager Apollo
In Commercial Distribution

  • 10841522106392 ()
91443B

  • Patient monitoring system module, interfacing

Flexport - 10841522106347

FLEXPORT-2 INTERFACE,FP 2,GE ENGSTROM CS,91436E
SPACELABS HEALTHCARE (WASHINGTON), INC
Flexport to PB840 Ventilator
In Commercial Distribution

  • 10841522106347 ()
91436E

  • Patient monitoring system module, interfacing

Flexport - 10841522106330

FLEXPORT 2 INTERFACE,GE AVANCE,91436D
SPACELABS HEALTHCARE (WASHINGTON), INC
Flexport to PB840 Ventilator
In Commercial Distribution

  • 10841522106330 ()
91436D

  • Patient monitoring system module, interfacing

Flexport - 10841522106323

FLEXPORT 2 INTERFACE,VIASYS,91436C
SPACELABS HEALTHCARE (WASHINGTON), INC
Flexport to PB840 Ventilator
In Commercial Distribution

  • 10841522106323 ()
91436C

  • Patient monitoring system module, interfacing

Flexport - 10841522106408

FLEXPORT-2,DRAEGER,91443C
SPACELABS HEALTHCARE (WASHINGTON), INC
Flexport2 to Drager Apollo
In Commercial Distribution

  • 10841522106408 ()
91443C

  • Patient monitoring system module, interfacing

DOLPHIX - 08032909624904

Rod to rod clamp.
CITIEFFE SRL
Rod to rod clamp
Not in Commercial Distribution

  • 08032909624904 ()
DF200030

  • External orthopaedic fixation system, single-use, sterile

GLOBUS - 08032625829812

The Globus Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimulators, Transcutaneous Electrical Nerve Stimulator. Premodulated Current Therapy Stimulator, and Microcurrent Therapy Stimulator.
DOMINO SRL
GLOBUS REVO TO GO
In Commercial Distribution

  • 08032625829812 ()
G5598

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

Tempo - 00195411060443

Tempo Foot, Right, Tan, Endo IP, 30cm, Category 5
COLLEGE PARK INDUSTRIES, INC.
TO RTEN 30 D5
In Commercial Distribution

  • 00195411060443 ()


  • Mechanical-resistance external ankle-foot prosthesis
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