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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No Description
Bird & Cronin, LLC
08141339
In Commercial Distribution

  • 00610570006106 ()


  • Gait rehabilitation system harness
No Description
edelweiss dentistry products gmbh
13214
In Commercial Distribution

  • 09120046321547 ()


  • Dental composite resin
  • Dental veneer, professional
No Description
edelweiss dentistry products gmbh
13213
In Commercial Distribution

  • 09120046321530 ()


  • Dental veneer, professional
  • Dental composite resin
No Description
edelweiss dentistry products gmbh
13212
In Commercial Distribution

  • 09120046321523 ()


  • Dental composite resin
  • Dental veneer, professional
No Description
edelweiss dentistry products gmbh
13108
In Commercial Distribution

  • 09120046321202 ()


  • Dental composite resin
  • Dental veneer, professional
No Description
edelweiss dentistry products gmbh
13107
In Commercial Distribution

  • 09120046321196 ()


  • Dental composite resin
  • Dental veneer, professional
No Description
edelweiss dentistry products gmbh
13106
In Commercial Distribution

  • 09120046321189 ()


  • Dental composite resin
  • Dental veneer, professional
No Description
Hasa Optix
HA-SET024
In Commercial Distribution

  • 05404027446745 ()
  • 05404027444727 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
No Description
BLEEP, LLC
100595
In Commercial Distribution

  • 10850003157082 ()
  • 00850003157085 ()


  • Home CPAP unit
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-084-009-005
In Commercial Distribution

  • 00858092006956 ()
00-084-009-005

  • General-purpose centrifuge IVD
No Description
JACE MEDICAL, LLC
115.407.24
Not in Commercial Distribution

  • 00851599007976 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
HARD MANUFACTURING CO., INC.
1711-BFP
In Commercial Distribution

  • 00852231007552 ()
  • 00852231007545 ()
1711-BFP

  • Paediatric bed
Blue Bouffant Cap 24" outer diameter.
Safesource Direct, L.L.C.
BHC30024BE
In Commercial Distribution

  • 10850037747259 ()
  • 00850037747252 ()
  • 20850037747256 ()


  • Surgical cap, single-use
White Bouffant Cap 21" outside diameter.
Safesource Direct, L.L.C.
BHC30024WE
In Commercial Distribution

  • 10850037747242 ()
  • 00850037747245 ()
  • 20850037747249 ()


  • Surgical cap, single-use
Contains Medical Device Mat. 10655152 (GTIN:04056869015378)
Siemens Shenzhen Magnetic Resonance Ltd.
10655153
In Commercial Distribution

  • 04056869015385 ()


  • Full-body MRI system, superconducting magnet
MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
10655152
In Commercial Distribution

  • 04056869015378 ()


  • Full-body MRI system, superconducting magnet
No Description
Sarstedt Aktiengesellschaft & Co.KG
77578010
In Commercial Distribution

  • 04038917189965 ()
  • 04038917113861 ()
77.578.010

  • 24-hour urine specimen container IVD, no additive
No Description
Dynarex Corporation
3202UB-1
In Commercial Distribution

  • 00840117332492 ()
  • 00840117334618 ()
  • 00840117332485 ()


  • Absorbent wound compression pad
ISQ Measurement Peg
Osstell AB
Osstell SmartPeg Type 24
In Commercial Distribution

  • 09010522000229 ()
  • 09010522001363 ()
100412

  • Dental implant stability resonance frequency analysis peg
Gold based noble metal
ARGEN CORPORATION, THE
121782
In Commercial Distribution

  • D818121782 ()
121782

  • Dental casting noble alloy
HumatroPen 24 mg is a reusable pen injector intended for use with Humatrope 24 mg cartridges
ELI LILLY AND COMPANY
MS9562
In Commercial Distribution

  • 30300029562017 ()
  • 00300029562016 ()
MS9562

  • Empty self-injector, mechanical
Dental bur holder
HAGER WORLDWIDE, INC.
355244
In Commercial Distribution

  • D2483552440 ()


  • Device sterilization/disinfection container, reusable
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-204-000
In Commercial Distribution

  • 00810052860459 ()
00-284-204-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-034-000
Not in Commercial Distribution

  • 00810052860411 ()
00-284-034-000

  • General-purpose centrifuge IVD
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
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-032-000
In Commercial Distribution

  • 00810052864754 ()
00-284-032-000

  • General-purpose centrifuge IVD
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
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-148-000
In Commercial Distribution

  • 00810052863269 ()
00-284-148-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-051-000
In Commercial Distribution

  • 00810052862644 ()
00-284-051-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-035-000
In Commercial Distribution

  • 00810052862620 ()
00-284-035-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-174-000
In Commercial Distribution

  • 00810052860442 ()
00-284-174-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-089-000
In Commercial Distribution

  • 00810052860428 ()
00-284-089-000

  • General-purpose centrifuge IVD
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
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
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
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
No Description
MAXTEC, LLC
R500P21-001
Not in Commercial Distribution

  • 20817770020817 ()


  • Exhaled-gas oesophageal intubation detector
No Description
ALIMED, INC.
925480
In Commercial Distribution

  • 00733657238884 ()
  • 00733657299380 ()
2970012634

  • Freestanding patient positioner, single-use
No Description
ALIMED, INC.
931720
In Commercial Distribution

  • 00733657239744 ()
2970013381

  • Freestanding patient positioner, reusable
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™ WS, v9 USA
Given Imaging, Inc.
FGS-0674
In Commercial Distribution

  • 07290110361167 ()


  • Video capsule endoscopy system application software
No Description
OSADA ELECTRIC CO.,LTD.
EXL-M40
In Commercial Distribution

  • 04580406860478 ()
3223

  • Dental laboratory power tool system
  • Line-powered dental drilling system
  • Dental power tool system, line-powered
No Description
OSADA ELECTRIC CO.,LTD.
XL-230
In Commercial Distribution

  • 04580406860461 ()
3192

  • Dental power tool system, line-powered
  • Dental laboratory power tool system
  • Line-powered dental drilling system
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)
Rogson Wax, Adhesive Prefabricated Plastic Form, green, corrugated, 24/24 gauge (GA), medium, 8 pieces.
MDC DENTAL
Rogson Wax, Adhesive Prefabricated Plastic Form
In Commercial Distribution

  • 07506338321792 ()


  • Dental casting wax
Cardinal Health Sterilization Wrap, Single Layer, CH300, 24 x 24 in. (60 x 60 cm)
Cardinal Health 200, LLC
CH310024
In Commercial Distribution

  • 50885380172791 ()
  • 20885380172790 ()
  • 10885380172793 ()
CH310024

  • Sterilization packaging, single-use
Cardinal Health Sterilization Wrap, Single Layer, CH100, 24 x 24 in. (60 x 60 cm)
Cardinal Health 200, LLC
CH110024
In Commercial Distribution

  • 50885380172692 ()
  • 20885380172691 ()
  • 10885380172694 ()
CH110024

  • Sterilization packaging, single-use
Spike electrode 5mm diameter 24 CH
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
32-4268
In Commercial Distribution

  • 00848657020589 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable
Spike electrode 3mm diameter 24 CH
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
32-4261
In Commercial Distribution

  • 00848657020466 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable
Roller barrel electrode conical 24 CH
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
32-4258
In Commercial Distribution

  • 00848657020428 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable
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