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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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Eckert & Ziegler Isotope Products, Inc. - 00810117210649

15.2" x 9.1" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3531
In Commercial Distribution

  • 00810117210649 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210632

8.9" x 8.9" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3530-1
In Commercial Distribution

  • 00810117210632 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210625

18.5" Circular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3529-1
In Commercial Distribution

  • 00810117210625 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210618

24.4" x 17.4" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3528-3
In Commercial Distribution

  • 00810117210618 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210601

16" x 10" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3528-2
In Commercial Distribution

  • 00810117210601 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210595

24.4" x 16.7" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3528-1
In Commercial Distribution

  • 00810117210595 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210588

23.9" x 16.4" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3525-2
In Commercial Distribution

  • 00810117210588 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210571

24" x 16.5" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3525-1
In Commercial Distribution

  • 00810117210571 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210564

24" x 17.5" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3517-2
In Commercial Distribution

  • 00810117210564 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210557

14" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3515-R07
In Commercial Distribution

  • 00810117210557 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210540

24" x 17.5" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3515-R06
In Commercial Distribution

  • 00810117210540 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210533

9" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3515-R05
In Commercial Distribution

  • 00810117210533 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210526

16" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3515-R04
In Commercial Distribution

  • 00810117210526 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210519

29" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3515-R03
In Commercial Distribution

  • 00810117210519 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210502

24" x 16.5" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3515-R02
In Commercial Distribution

  • 00810117210502 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210496

18" Rectangular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3515-R01
In Commercial Distribution

  • 00810117210496 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210489

24" Circular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3515-C04
In Commercial Distribution

  • 00810117210489 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210472

20" Circular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3515-C03
In Commercial Distribution

  • 00810117210472 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210465

18" Circular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3515-C02
In Commercial Distribution

  • 00810117210465 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210458

14" Circular Flood Source
Eckert & Ziegler Isotope Products, Inc.
A3515-C01
In Commercial Distribution

  • 00810117210458 ()


  • Nuclear medicine phantom, flood source

Eckert & Ziegler Isotope Products, Inc. - 00810117210298

Quality Assurance Line Source
Eckert & Ziegler Isotope Products, Inc.
A3446
In Commercial Distribution

  • 00810117210298 ()


  • Nuclear medicine phantom, line source

Eckert & Ziegler Isotope Products, Inc. - 00810117210274

Quality Assurance Line Source
Eckert & Ziegler Isotope Products, Inc.
A3407-4
In Commercial Distribution

  • 00810117210274 ()


  • Nuclear medicine phantom, line source

Eckert & Ziegler Isotope Products, Inc. - 00810117210250

Quality Assurance Line Source
Eckert & Ziegler Isotope Products, Inc.
A3445
In Commercial Distribution

  • 00810117210250 ()


  • Nuclear medicine phantom, line source

Eckert & Ziegler Isotope Products, Inc. - 00810117210243

Quality Assurance Line Source
Eckert & Ziegler Isotope Products, Inc.
A3444
In Commercial Distribution

  • 00810117210243 ()


  • Nuclear medicine phantom, line source

Eckert & Ziegler Isotope Products, Inc. - 00810117210137

Quality Assurance Line Source
Eckert & Ziegler Isotope Products, Inc.
A3432-2
In Commercial Distribution

  • 00810117210137 ()


  • Nuclear medicine phantom, line source

Eckert & Ziegler Isotope Products, Inc. - 00810117210120

Quality Assurance Line Source
Eckert & Ziegler Isotope Products, Inc.
A3432
In Commercial Distribution

  • 00810117210120 ()


  • Nuclear medicine phantom, line source

Eckert & Ziegler Isotope Products, Inc. - 00810117210113

Quality Assurance Line Source
Eckert & Ziegler Isotope Products, Inc.
A3402-C16285
In Commercial Distribution

  • 00810117210113 ()


  • Nuclear medicine phantom, line source

Eckert & Ziegler Isotope Products, Inc. - 00810117210106

Quality Assurance Line Source
Eckert & Ziegler Isotope Products, Inc.
A3402-C12000
In Commercial Distribution

  • 00810117210106 ()


  • Nuclear medicine phantom, line source

Eckert & Ziegler Isotope Products, Inc. - 00810117210083

Quality Assurance Line Source
Eckert & Ziegler Isotope Products, Inc.
A3412-7
In Commercial Distribution

  • 00810117210083 ()


  • Nuclear medicine phantom, line source

Pinestar Technology Inc - 00850021301460

Jumbo Flood Phantom
PINESTAR TECHNOLOGY, INC.
NMC-76801
In Commercial Distribution

  • 00850021301460 ()


  • Nuclear medicine phantom, flood source

Pinestar Technology Inc - 00850021301453

Flood Phantom
PINESTAR TECHNOLOGY, INC.
76-801
In Commercial Distribution

  • 00850021301453 ()


  • Nuclear medicine phantom, flood source

Sanders Medical Products - 00850055164017

No Description
Sanders Medical Products, Inc.
PET-LINE
In Commercial Distribution

  • 00850055164017 ()


  • Nuclear medicine phantom, line source

Flood Phantom - 00718175000540

Flood Phantom, Rectangular, Fillable
BIODEX MEDICAL SYSTEMS, INC.
243-054
In Commercial Distribution

  • 00718175000540 ()
243-054

  • Nuclear medicine phantom, flood source

Metafer - 04250406460007

No Description
MetaSystems Hard & Software GmbH
Microscopic image acquisition
In Commercial Distribution

  • 04250406460007 ()


  • Laboratory instrument/analyser application software IVD

MagPro - 05713484020437

Magnetic coil for he Axilum Robotics’ TMS-Cobot TS MV solution (K182768) which is an accessory to the predicate MagVenture TMS Therapy System (K150641, K171481 and K171967).
Tonica Elektronik A/S
Cool-B65 CO
In Commercial Distribution

  • 05713484020437 ()
9016E0151

  • Magnetic neural stimulation system

Philips one - 00075020102300

No Description
PHILIPS ORAL HEALTHCARE, LLC
PAL109/CO
In Commercial Distribution

  • 00075020102300 ()


  • Basic electric toothbrush

Data Acquisition Service for NAVIS-EX - 04987669101421

Data Acquisition Service for NAVIS-EX (hereafter referred to as DAS) acquires data from measurement devices and transfers it to NAVIS-EX. In addition to acquisition of measurement data, DAS registers patients newly registered with the ALScan/CEM-530 to NAVIS-EX.
NIDEK CO.,LTD.
1.0
In Commercial Distribution

  • 04987669101421 ()


  • Eye anterior segment analyser software

Arthrex® - 00888867446168

BLNT FOR HF PANO SHEATH,w/handle
ARTHREX, INC.
AR-3375-4214
In Commercial Distribution

  • 00888867446168 ()
AR-3375-4214

  • Rigid endoscope obturator

Arthrex® - 00888867446144

TROCAR FOR HF PANO SHTH,w/handle
ARTHREX, INC.
AR-3375-4212
In Commercial Distribution

  • 00888867446144 ()
AR-3375-4212

  • Laparoscopic trocar blade, reusable

Arthrex® - 00888867446137

CONICAL OBTR,HF PANO SHTH w/handle
ARTHREX, INC.
AR-3375-4211
In Commercial Distribution

  • 00888867446137 ()
AR-3375-4211

  • Rigid endoscope obturator
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