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
ACCUTRON, INC.
33016-16
In Commercial Distribution

  • 00813830025774 ()
33016-16

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-15
In Commercial Distribution

  • 00813830025767 ()
33016-15

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-14
In Commercial Distribution

  • 00813830025750 ()
33016-14

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-12
In Commercial Distribution

  • 00813830025736 ()
33016-12

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-11
In Commercial Distribution

  • 00813830025729 ()
33016-11

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33016-10
In Commercial Distribution

  • 00813830025712 ()
33016-10

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33015-9
In Commercial Distribution

  • 00813830025699 ()
33015-9

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33015-16
In Commercial Distribution

  • 00813830025675 ()
33015-16

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33015-15
In Commercial Distribution

  • 00813830025668 ()
33015-15

  • Anaesthesia face mask, single-use
No Description
ACCUTRON, INC.
33015-14
In Commercial Distribution

  • 00813830025651 ()
33015-14

  • Anaesthesia face mask, single-use
PureCeption 24 - Determination Bi-Layer Kit. 6x12 mL each of 40% UPPER and 80% LOWER Phase In HEPES-buffered HTF
Origio A/S
ART-2024
In Commercial Distribution

  • 60888937818583 ()


  • IVF medium kit
A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device.
NOVOSCI CORP.
301124-000
In Commercial Distribution

  • B0663011240000 ()
  • B0663011240006 ()
301124-000

  • Cardiopulmonary bypass system priming set
No Description
Bird & Cronin, LLC
90002664
In Commercial Distribution

  • 50610570078283 ()
  • 00610570078288 ()


  • Knee sling
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-192-000
In Commercial Distribution

  • 00810052860701 ()
00-384-192-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-174-000
In Commercial Distribution

  • 00810052860695 ()
00-384-174-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-148-000
In Commercial Distribution

  • 00810052860688 ()
00-384-148-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-034-000
In Commercial Distribution

  • 00810052860657 ()
00-384-034-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-018-000
In Commercial Distribution

  • 00810052860633 ()
00-384-018-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-024-000
In Commercial Distribution

  • 00810052860404 ()
00-284-024-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-273-000
In Commercial Distribution

  • 00810052864662 ()
00-384-273-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-252-000
In Commercial Distribution

  • 00810052864587 ()
00-384-252-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-273-000
In Commercial Distribution

  • 00810052864181 ()
00-284-273-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-184-264-000
In Commercial Distribution

  • 00810052863931 ()
00-184-264-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-037-000
In Commercial Distribution

  • 00810052863849 ()
00-384-037-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-260-000
In Commercial Distribution

  • 00810052863726 ()
00-384-260-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-184-260-000
In Commercial Distribution

  • 00810052863672 ()
00-184-260-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-213-000
In Commercial Distribution

  • 00810052863221 ()
00-384-213-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-009-001
In Commercial Distribution

  • 00810052863146 ()
00-284-009-001

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-215-000
In Commercial Distribution

  • 00810052862774 ()
00-384-215-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-214-000
In Commercial Distribution

  • 00810052862767 ()
00-384-214-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-384-038-000
In Commercial Distribution

  • 00810052862736 ()
00-384-038-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-184-047-000
In Commercial Distribution

  • 00810052862521 ()
00-184-047-000

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
CA384009
In Commercial Distribution

  • 00810052862255 ()
CA384009

  • General-purpose centrifuge IVD
No Description
Ventana Medical Systems, Inc.
05251583001
In Commercial Distribution

  • 07613336125533 ()
05251583001

  • Assay container IVD, single-use
No Description
GLOBAL SURGICAL CORPORATION
S 600024
Not in Commercial Distribution

  • 00810040253157 ()


  • ENT cabinet
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .5mm Xenolite 800 NL Size S8T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
R8KILTBLOCKERS8T
In Commercial Distribution

  • 00840331272734 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .25mm Xenolite 800 NL Size S8T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
U8KILTBLOCKERS8T
In Commercial Distribution

  • 00840331272857 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .35mm Xenolite 800 NL Size S8T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
S8KILTBLOCKERS8T
In Commercial Distribution

  • 00840331272796 ()


  • Radiation shielding apron
Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840724 ()
  • 04260764840571 ()

  • Fits for premature infants weighting 200-800g
24021703-S

  • Infant recumbent sleep positioner
Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840564 ()
  • 04260764840717 ()

  • Fits for premature infants weighting 800-2000g
24021703-M

  • Infant recumbent sleep positioner
Thyreoglobulin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381638
In Commercial Distribution

  • 00630414972077 ()
LKTY1(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Thyroglobulin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388175
In Commercial Distribution

  • 00630414979472 ()
LTYCVM

  • Thyroglobulin antibody IVD, control
VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Tg Set: Thyroglobulin (Tg) TU Set: T-Uptake (TU)
Lgc Clinical Diagnostics, Inc.
908bc
In Commercial Distribution

  • 00850011135372 ()


  • Thyroglobulin IVD, control
  • Multiple thyroid hormone uptake (T-uptake) IVD, control
The ASA LASER HIRO 3.0 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG Laser source.
EL.EN. SPA
M080K1
In Commercial Distribution

  • 08057017760214 ()
M080K1

  • Musculoskeletal infrared phototherapy unit, non-wearable
EnviroSorb® CommodeShield™ 24 x 24, 3-Ply Absorbent Commode Bag elastic draw string closure Packaged in bags of 5
LDI Solutions, LLC
ESCS-2424
In Commercial Distribution

  • 00860010353264 ()
ESCS-2424

  • Commode, manual
ROUX Wound Retractor, 6 3/4", (170 mm), double ended, 28 x 24 mm, 43 x 24 mm, non-sterile, reusable
Aesculap AG
BT028R
In Commercial Distribution

  • 04038653030057 ()
BT028R

  • Hand-held surgical retractor, reusable
KILT BLOCKER - Standard Size with Hook and Loop Closure, .5mm Xenolite 800 NL Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
R8KILTBLOCKER24X24
In Commercial Distribution

  • 00840331272765 ()


  • Radiation shielding apron
HALF APRON - Standard Size with Hook and Loop Closure, .25mm Xenolite 800 NL Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
U8HALF6H
In Commercial Distribution

  • 00840331272635 ()


  • Radiation shielding apron
HALF APRON - Standard Size with Hook and Loop Closure, .35mm Xenolite 800 NL Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
S8HALF6H
In Commercial Distribution

  • 00840331272499 ()


  • Radiation shielding apron
HALF APRON - Standard Size with Hook and Loop Closure, .5mm Xenolite 800 NL Size 6, 24"L X 24"W
BURLINGTON MEDICAL, LLC
R8HALF6H
In Commercial Distribution

  • 00840331272352 ()


  • Radiation shielding apron
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