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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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Horizon 24 Centrifuge, Fisher - 00810052860398

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-018-000
In Commercial Distribution

  • 00810052860398 ()
00-284-018-000

  • General-purpose centrifuge IVD

Horizon 24 Centrifuge, Davita - 00810052860381

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-008-000
In Commercial Distribution

  • 00810052860381 ()
00-284-008-000

  • General-purpose centrifuge IVD

DASH Flex 24, Drucker - 00810052860060

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-184-009-000
In Commercial Distribution

  • 00810052860060 ()
00-184-009-000

  • General-purpose centrifuge IVD

Horizon 24 Flex, Drucker - 00810052860039

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-009-000
In Commercial Distribution

  • 00810052860039 ()
00-384-009-000

  • General-purpose centrifuge IVD

Horizon 24 Centrifuge, Woodley - 00810052862637

General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-038-000
In Commercial Distribution

  • 00810052862637 ()
00-284-038-000

  • General-purpose centrifuge IVD

SuperBall 24 degrees Up - 00850000630024

The SuperBall™ Meniscal Repair System 24 Up is a single-patient and single-use device for repair procedures in the lateral and medial meniscus and for meniscal implant fixation. The SuperBall™ System is provided EtO sterile.
ARCURO MEDICAL LTD
A
In Commercial Distribution

  • 00850000630024 ()
SBD-SB-12-024

  • Polyester suture, non-bioabsorbable, multifilament

EverFlo - 00606959032750

EVERFLO w/O2 Percentage Indicator, 120V US, BRAZIL
Respironics, Inc.
EVERFLO w/O2 Percentage Indicator, 120V US, BR
In Commercial Distribution

  • 00606959032750 ()
1020002BR

  • Stationary oxygen concentrator

PillCam - 07290110361167

PillCam™ WS, v9 USA
Given Imaging, Inc.
FGS-0674
In Commercial Distribution

  • 07290110361167 ()


  • Video capsule endoscopy system application software

BD MAX™ Enteric Parasite Panel (US/CAN) - 00382904433802

BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer tubes, 25 Septum Caps, 24 Strips Containing, Wash Buffer, Elution Buffer, Neutralization Buffer
Geneohm Sciences Canada Inc
443380
Not in Commercial Distribution

  • 00382904433802 ()
443380

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

BioMIM Mini Twin Brackets - 00840273916789

RO LL/LR2 22/0/0/0 100PK
World Class Technology Corporation
905.2036-100
In Commercial Distribution

  • 00840273916789 ()
905.2036-100

  • Orthodontic bracket, metal
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