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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 Angled Standard Probe - B619GPROSTDANGPROBE0

GammaPro Angled Standard Probe used for wireless ionizing radiation detection.
Kubtec
K0021C01
In Commercial Distribution

  • B619GPROSTDANGPROBE0 ()


  • Mobile gamma camera system

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 - 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

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

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)

Origin Data Management / Patient Data Manager - 04056481132453

No Description
Brainlab AG
2.3.1
Not in Commercial Distribution

  • 04056481132453 ()
25100-12A

  • Radiology picture archiving and communication system workstation

Origin Data Management / Patient Data Manager - 04056481006662

No Description
Brainlab AG
2.3
Not in Commercial Distribution

  • 04056481006662 ()
25100-12

  • Radiology picture archiving and communication system workstation

Origin 125° Short Neck Hip Stem - 09348215083557

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0825
In Commercial Distribution

  • 09348215083557 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215083540

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0806
In Commercial Distribution

  • 09348215083540 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017835

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1803
In Commercial Distribution

  • 09348215017835 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017828

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1603
In Commercial Distribution

  • 09348215017828 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017811

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1503
In Commercial Distribution

  • 09348215017811 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017804

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1403
In Commercial Distribution

  • 09348215017804 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017798

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1303
In Commercial Distribution

  • 09348215017798 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017781

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1203
In Commercial Distribution

  • 09348215017781 ()


  • Coated femoral stem prosthesis, modular
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