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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 Standard Probe with Tablet Carry Case - B619GPROSTDKIT0

GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0018C02
In Commercial Distribution

  • B619GPROSTDKIT0 ()


  • Mobile gamma camera system

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 - 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

Origin Short 125deg Trial Neck - 09348215081423

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-027
In Commercial Distribution

  • 09348215081423 ()


  • Surgical implant template, reusable

Origin DAA Stem, Coxa Vara - 09348215092825

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1804
In Commercial Distribution

  • 09348215092825 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092818

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1604
In Commercial Distribution

  • 09348215092818 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092801

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1504
In Commercial Distribution

  • 09348215092801 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092795

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1404
In Commercial Distribution

  • 09348215092795 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092788

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1304
In Commercial Distribution

  • 09348215092788 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092771

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1204
In Commercial Distribution

  • 09348215092771 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092764

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1104
In Commercial Distribution

  • 09348215092764 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092757

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1004
In Commercial Distribution

  • 09348215092757 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Coxa Vara - 09348215092740

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0904
In Commercial Distribution

  • 09348215092740 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088507

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1413
In Commercial Distribution

  • 09348215088507 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088491

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1412
In Commercial Distribution

  • 09348215088491 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088484

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1313
In Commercial Distribution

  • 09348215088484 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088378

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0812
In Commercial Distribution

  • 09348215088378 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088569

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1813
In Commercial Distribution

  • 09348215088569 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088552

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1812
In Commercial Distribution

  • 09348215088552 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088545

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1613
In Commercial Distribution

  • 09348215088545 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088538

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1612
In Commercial Distribution

  • 09348215088538 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088521

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1513
In Commercial Distribution

  • 09348215088521 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088514

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1512
In Commercial Distribution

  • 09348215088514 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088477

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1312
In Commercial Distribution

  • 09348215088477 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088460

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1213
In Commercial Distribution

  • 09348215088460 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088453

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1212
In Commercial Distribution

  • 09348215088453 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088446

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1113
In Commercial Distribution

  • 09348215088446 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088439

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1112
In Commercial Distribution

  • 09348215088439 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088422

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1013
In Commercial Distribution

  • 09348215088422 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088415

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1012
In Commercial Distribution

  • 09348215088415 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088408

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0913
In Commercial Distribution

  • 09348215088408 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, Standard Offset - 09348215088392

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0912
In Commercial Distribution

  • 09348215088392 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215088385

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0813
In Commercial Distribution

  • 09348215088385 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215083533

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0805
In Commercial Distribution

  • 09348215083533 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036454

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1803
In Commercial Distribution

  • 09348215036454 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036447

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1603
In Commercial Distribution

  • 09348215036447 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036430

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1503
In Commercial Distribution

  • 09348215036430 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036423

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1403
In Commercial Distribution

  • 09348215036423 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036416

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1303
In Commercial Distribution

  • 09348215036416 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036409

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1203
In Commercial Distribution

  • 09348215036409 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036393

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1103
In Commercial Distribution

  • 09348215036393 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036386

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1003
In Commercial Distribution

  • 09348215036386 ()


  • Coated femoral stem prosthesis, modular

Origin DAA Stem, High Offset - 09348215036379

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-0903
In Commercial Distribution

  • 09348215036379 ()


  • Coated femoral stem prosthesis, modular
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