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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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GammaPro Laparoscopic Probe - B619GPROLAPPROBE0

GammaPro Laparoscopic Probe used for wireless ionizing radiation detection.
Kubtec
K0020C01
In Commercial Distribution

  • B619GPROLAPPROBE0 ()


  • Mobile gamma camera system

GammaPro Laparoscopic Probe with Tablet and Carry Case - B619GPROLAPKIT0

GammaPro Laparoscopic Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0020C02
In Commercial Distribution

  • B619GPROLAPKIT0 ()


  • Mobile gamma camera system

GammaPro High Sensitivity Probe - B619GPROHISPROBE0

GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.
Kubtec
K0019C01
In Commercial Distribution

  • B619GPROHISPROBE0 ()


  • Mobile gamma camera system

GammaPro Hi-Sense Probe with Tablet and Carry Case - B619GPROHISKIT0

GammaPro Hi-Sense Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0019C02
In Commercial Distribution

  • B619GPROHISKIT0 ()


  • Mobile gamma camera system

GammaPro Carry Case and Tablet - B619GPROCASETABL2

Table with installed software is used with wireless battery powered probes (different shapes and sizes) to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity.
Kubtec
K0017C01
In Commercial Distribution

  • B619GPROCASETABL2 ()


  • Mobile gamma camera system

STAT PROFILE - 00385480491877

Stat Profile pHOx Ultra/CCX Control CO-Ox Tri Level L7, 8 ,9 (amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480491877 ()
  • 00385489491878 ()
49187

  • Assisted reproduction centrifuge tube

STAT PROFILE - 00385480491846

Stat Profile pHOx Ultra/CCX Control Chemistry L4, 5 (amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480491846 ()
  • 00385489491847 ()
49184

  • Assisted reproduction centrifuge tube

STAT PROFILE - 00385480489355

Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480489355 ()
  • 00385489489356 ()
48935

  • Assisted reproduction centrifuge tube

Centrifuge Tube 50 mL - 17350025914609

No Description
Hertart ApS
16106
In Commercial Distribution

  • 27350025914606 ()
  • 17350025914609 ()
  • 07350025914602 ()


  • Assisted reproduction centrifuge tube

Centrifuge Tube 15 mL - 17350025914593

No Description
Hertart ApS
16105
In Commercial Distribution

  • 27350025914590 ()
  • 17350025914593 ()
  • 07350025914596 ()


  • Assisted reproduction centrifuge tube

Sample Tube 5 mL - 17350025914579

No Description
Hertart ApS
16103
In Commercial Distribution

  • 17350025914579 ()
  • 27350025914576 ()
  • 07350025914572 ()


  • Assisted reproduction centrifuge tube

Oocyte Collection Tube 14 mL - 17350025914555

No Description
Hertart ApS
16101
In Commercial Distribution

  • 07350025914558 ()
  • 17350025914555 ()
  • 27350025914552 ()


  • Assisted reproduction centrifuge tube

SoloMobile - 05711665004009

Gamma Camera System
Ddd-Diagnostic A/S
SoloMobile Gamma Camera System
In Commercial Distribution

  • 05711665004009 ()

  • Weight: 252 Kilogram
  • Height: 173 Centimeter
  • Depth: 138 Centimeter
  • Width: 70 Centimeter
9SOL2210

  • Mobile gamma camera system

SENTINELLA - 08437018413027

Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. It provides scintigraphic images of specific parts of the body based on the detection of gamma rays emitted by the radioisotopes injected into patients. Sentinella presents the following modalities: • Sentinella 102 (this record) • Sentinella 102 Horus
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
SENTINELLA 102 HORUS
In Commercial Distribution

  • 08437018413027 ()

  • Height: 185 Centimeter
  • Depth: 77 Centimeter
  • Width: 63 Centimeter
  • Weight: 134 Kilogram
FP-0055

  • Mobile gamma camera system

SENTINELLA - 08437018413010

Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. It provides scintigraphic images of specific parts of the body based on the detection of gamma rays emitted by the radioisotopes injected into patients. Sentinella presents the following modalities: • Sentinella 102 (this record) • Sentinella 102 Horus
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
SENTINELLA 102
In Commercial Distribution

  • 08437018413010 ()

  • Height: 185 Centimeter
  • Depth: 77 Centimeter
  • Width: 63 Centimeter
  • Weight: 134 Kilogram
FP-0040

  • Mobile gamma camera system

OrthoMedFlex - M7161111818000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1800
In Commercial Distribution

  • M7161111818000 ()
111-18-1800

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111816000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 16, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1600
In Commercial Distribution

  • M7161111816000 ()
111-18-1600

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111815000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 15, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1500
In Commercial Distribution

  • M7161111815000 ()
111-18-1500

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111814000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 14, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1400
In Commercial Distribution

  • M7161111814000 ()
111-18-1400

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111813000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1300
In Commercial Distribution

  • M7161111813000 ()
111-18-1300

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111812000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 12, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1200
In Commercial Distribution

  • M7161111812000 ()
111-18-1200

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111811000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 11, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1100
In Commercial Distribution

  • M7161111811000 ()
111-18-1100

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111810000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 10, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1000
In Commercial Distribution

  • M7161111810000 ()
111-18-1000

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111809000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 9, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0900
In Commercial Distribution

  • M7161111809000 ()
111-18-0900

  • Press-fit femoral stem prosthesis

OrthoMedFlex - M7161111808000

Origin Hip Stem, Standard Offset Collarless, Cementless - Size 8, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0800
In Commercial Distribution

  • M7161111808000 ()
111-18-0800

  • Press-fit femoral stem prosthesis

Xpert Flu - 07332940001070

Xpert Flu kit; 10 test kit
CEPHEID
GXFLU-10A
Not in Commercial Distribution

  • 07332940001070 ()
GXFLU-10A

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Premier Evacuator 110V Air Filtration System - D69190063000

Premier Evacuator 110V Air Filtration System. Contains one Premier Evacuator 110V unit, one detachable cord, and Disposable Filter Pack (5 filters - reorder number 9006290).
DERMATOLOGIC LAB AND SUPPLY, INC.
9006300
In Commercial Distribution

  • D69190063000 ()
9006300

  • Surgical plume evacuation system

Premier Evacuator 220V Air Filtration System - D69190062980

Premier Evacuator 220V Air Filtration System. Contains one Premier Evacuator 220V unit, one detachable cord, and Disposable Filter Pack (5 filters - reorder number 9006290).
DERMATOLOGIC LAB AND SUPPLY, INC.
9006298
In Commercial Distribution

  • D69190062980 ()
9006298

  • Surgical plume evacuation system

Premier Filter Pack for Premier Evacuator - D69190062900

Premier Filter Pack for Premier Evacuator. Contains five disposable Premier filters.
DERMATOLOGIC LAB AND SUPPLY, INC.
9006290
In Commercial Distribution

  • D69190062901 ()
  • D69190062900 ()
9006290

  • Surgical plume evacuation system

NA - 10653405005179

CABLE/STRAIN REL. BLACK
Conmed Corporation
711-7760
In Commercial Distribution

  • 10653405005179 ()
711-7760

  • Surgical plume evacuation system

CORE DYNAMICS - 10653405045663

Laparoscopic Smoke Eliminator
Conmed Corporation
CD3900
Not in Commercial Distribution

  • 20653405045660 ()
  • 10653405045663 ()
  • 00653405045666 ()
CD3900

  • Surgical plume evacuation system

ZIP Pen - 10614559105757

Zip Pen Extension Nozzle 5.2" (13.2 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
2560J
In Commercial Distribution

  • 10614559105757 ()
  • 50614559105755 ()
  • 30614559105751 ()
2560J

  • Surgical plume evacuation system

Megadyne - 10614559105733

Tube Adapter
MEGADYNE MEDICAL PRODUCTS, INC.
2151J
In Commercial Distribution

  • 10614559105733 ()
  • 30614559105737 ()
2151J

  • Surgical plume evacuation system

Megadyne - 10614559105672

MEGADYNE ACE BLADE 700, 2.5" Modified Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, E Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME725M1E
In Commercial Distribution

  • 10614559105672 ()
  • 30614559105676 ()
ME725M1E

  • Surgical plume evacuation system

Megadyne - 10614559105665

MEGADYNE ACE BLADE 700, 2.5" Standard Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, E Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME7251E
In Commercial Distribution

  • 10614559105665 ()
  • 30614559105669 ()
ME7251E

  • Surgical plume evacuation system

Megadyne - 10614559105658

MEGADYNE ACE BLADE 700, 2.5" Modified Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, C Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME725M1C
In Commercial Distribution

  • 10614559105658 ()
  • 30614559105652 ()
ME725M1C

  • Surgical plume evacuation system

Megadyne - 10614559105641

MEGADYNE ACE BLADE 700, 2.5" Standard Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, C Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME7251C
In Commercial Distribution

  • 10614559105641 ()
  • 30614559105645 ()
ME7251C

  • Surgical plume evacuation system

Megadyne - 10614559105405

Connector Smoke Evacuator Universal Non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2150J
In Commercial Distribution

  • 10614559105405 ()
  • 30614559105409 ()
2150J

  • Surgical plume evacuation system

Megadyne - 10614559105399

Connector 22mm ID Filter to Tubing Non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2145J
In Commercial Distribution

  • 10614559105399 ()
  • 30614559105393 ()
2145J

  • Surgical plume evacuation system

Megadyne - 10614559105382

Mega Vac Connector Filter to Tubing Non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2140J
In Commercial Distribution

  • 10614559105382 ()
  • 30614559105386 ()
2140J

  • Surgical plume evacuation system
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