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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STANDARD SHIELD - 24 x 24 - 0.50mm Lead Equivalence -REGULAR LEADED PROTECTIVE MEDIA - Star Base
Techno-Aide, Inc.
LPS-S2424
In Commercial Distribution

  • G242LPSS242490 ()
  • G242LPSS24249 ()
LPS-S2424

  • Radiation shielding panel, portable/mobile
STANDARD SHIELD - 24 x 24 - 0.50mm Lead Equivalence -LEAD FREE PROTECTIVE MEDIA - Star Base
Techno-Aide, Inc.
LPSG-S2424
In Commercial Distribution

  • G242LPSGS242490 ()
  • G242LPSGS24249 ()
LPSG-S2424

  • Radiation shielding panel, portable/mobile
Fantasy Assorted case of 12-packs (24 Lubricated, 24 3 Styles Assorted)( case of 48)
GLOBAL PROTECTION CORP.
L610002C
In Commercial Distribution

  • 80726893114018 ()
  • 20726893114016 ()


  • Basic male condom, Hevea-latex
55" 24 Hour Smallbore Ext Set w/Bravo 24®, 2 Clamps, Rotating Luer
ICU MEDICAL, INC.
B9977
In Commercial Distribution

  • 10887709019895 ()
  • 00887709019898 ()


  • Basic intravenous administration set, noninvasive
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6275
In Commercial Distribution

  • B126KR62750 ()
KR6275

  • Thyroglobulin antibody IVD, kit, radioimmunoassay
A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6270
In Commercial Distribution

  • B126KR62700 ()
KR6270

  • Thyroglobulin antibody IVD, kit, radioimmunoassay
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
No Description
HARD MANUFACTURING CO., INC.
1711-BFP
In Commercial Distribution

  • 00852231007552 ()
  • 00852231007545 ()
1711-BFP

  • Paediatric bed
No Description
JACE MEDICAL, LLC
115.407.24
Not in Commercial Distribution

  • 00851599007976 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
ENDOPERFECTION LIMITED
HSB25ASS 1
In Commercial Distribution

  • 05060940375397 ()


  • Endodontic broach, serrated, reusable
No Description
ENDOPERFECTION LIMITED
HSB21AS1
In Commercial Distribution

  • 05060940375304 ()


  • Endodontic broach, serrated, reusable
No Description
Hasa Optix
HA-SET024
In Commercial Distribution

  • 05404027446745 ()
  • 05404027444727 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
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
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
No Description
ALIMED, INC.
931720
In Commercial Distribution

  • 00733657239744 ()
2970013381

  • Freestanding patient positioner, reusable
No Description
ALIMED, INC.
925480
In Commercial Distribution

  • 00733657238884 ()
  • 00733657299380 ()
2970012634

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

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


  • Surgical cap, single-use
Blue Bouffant Cap 24" outer diameter.
Safesource Direct, L.L.C.
BHC30024BE
In Commercial Distribution

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


  • Surgical cap, single-use
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
BLEEP, LLC
100595
In Commercial Distribution

  • 10850003157082 ()
  • 00850003157085 ()


  • Home CPAP unit
No Description
SIZEWISE RENTALS, L.L.C.
DAC24
In Commercial Distribution

  • 00845699000517 ()


  • Commode, manual
No Description
Bird & Cronin, LLC
90003393
In Commercial Distribution

  • 00610570139415 ()
  • 00610570189946 ()


  • Hot/cold therapy pack, single-use
Dental bur holder
HAGER WORLDWIDE, INC.
355244
In Commercial Distribution

  • D2483552440 ()


  • Device sterilization/disinfection container, reusable
No Description
Bird & Cronin, LLC
08143392
In Commercial Distribution

  • 00610570189496 ()


  • Hot/cold therapy pack, single-use
No Description
Bird & Cronin, LLC
08141339
In Commercial Distribution

  • 00610570006106 ()


  • Gait rehabilitation system harness
No Description
edelweiss dentistry products gmbh
13213
In Commercial Distribution

  • 09120046321530 ()


  • Dental veneer, professional
  • Dental composite resin
No Description
DARCO INTERNATIONAL, INC.
E62655
In Commercial Distribution

  • 10609271611518 ()
  • 00609271611511 ()
  • 20609271611515 ()
E62655

  • Knee immobilizer
No Description
edelweiss dentistry products gmbh
13214
In Commercial Distribution

  • 09120046321547 ()


  • Dental composite resin
  • Dental veneer, professional
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
ISQ Measurement Peg
Osstell AB
Osstell SmartPeg Type 24
In Commercial Distribution

  • 09010522000229 ()
  • 09010522001363 ()
100412

  • Dental implant stability resonance frequency analysis peg
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
77.578.010
In Commercial Distribution

  • 04038917189965 ()
  • 04038917113861 ()
77.578.010

  • 24-hour urine specimen container IVD, no additive
Gold based noble metal
ARGEN CORPORATION, THE
121782
In Commercial Distribution

  • D818121782 ()
121782

  • Dental casting noble alloy
No Description
Dynarex Corporation
3202UB-1
In Commercial Distribution

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


  • Absorbent wound compression pad
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
00-284-174-000
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
00-284-034-000
Not in Commercial Distribution

  • 00810052860411 ()
00-284-034-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-018-000
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
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
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