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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shenb Co., Ltd.
SH-TIP
In Commercial Distribution

  • 08800017100234 ()
  • 08800017100340 ()
  • 08800017100357 ()
  • 08800017100364 ()


  • Radio-frequency skin surface treatment system
The Sensifirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage - Temporary reduction in the appearance of cellulite
EL GLOBAL TRADE LTD
CEL100US04SNS
In Commercial Distribution

  • 05060445341309 ()


  • Radio-frequency skin surface treatment system
The sensiLift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
EL GLOBAL TRADE LTD
ST100US01SNS
In Commercial Distribution

  • 05060445341125 ()


  • Radio-frequency skin surface treatment system
The sensiFirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage - Temporary reduction in the appearance of cellulite
EL GLOBAL TRADE LTD
CEL100US01SNS
In Commercial Distribution

  • 05060445341118 ()


  • Radio-frequency skin surface treatment system
The Sensilift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
EL GLOBAL TRADE LTD
ST100US04SNS
In Commercial Distribution

  • 05060445341255 ()


  • Radio-frequency skin surface treatment system
Stent System
BOSTON SCIENTIFIC CORPORATION
M00574660
In Commercial Distribution

  • 08714729820550 ()

  • 10 mm Diameter
  • 40 mm Length


  • Ophthalmic cryosurgical system control unit
The Nutritone Facial Beauty System is a gentle rejuvenating treatment which provides your skin with gentle electronic stimulation.
Isomers Laboratories Inc
T300
In Commercial Distribution

  • 00884785000017 ()


  • Radio-frequency skin surface treatment system
The BellaVisage Hybrid is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n BellaVisage Hybrid is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
HOME SKINOVATIONS LTD
BellaVisage Hybrid
In Commercial Distribution

  • 17290112452013 ()
  • 07290112452016 ()
7290112452016

  • Radio-frequency skin surface treatment system
The Silk'n Titan Allways is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n Titan Allways is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The Silk'n Titan AllWays device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
HOME SKINOVATIONS LTD
Titan AllWays
In Commercial Distribution

  • 17290112451559 ()
  • 07290112451552 ()
7290112451552

  • Radio-frequency skin surface treatment system
The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles.
HOME SKINOVATIONS LTD
BellaVisage
In Commercial Distribution

  • 17290112450224 ()
  • 07290112450227 ()
  • 27290112450221 ()
7290112450227

  • Radio-frequency skin surface treatment system
Fractora 24P
INMODE M.D LTD
AG602426A
In Commercial Distribution

  • 17290016633150 ()
  • 07290016633153 ()
AG602426A

  • Radio-frequency skin surface treatment system
The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles.
HOME SKINOVATIONS LTD
Titan
In Commercial Distribution

  • 07290015763851 ()
  • 17290015763858 ()
  • 27290015763855 ()
7290015763851

  • Radio-frequency skin surface treatment system
EYE PACK
Cardinal Health 200, LLC
SEY53BSV12
In Commercial Distribution

  • 50197106713769 ()
  • 10197106713761 ()
SEY53BSV12

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY73EYCHA
In Commercial Distribution

  • 50197106708949 ()
  • 10197106708941 ()
SEY73EYCHA

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY41EPBHA
In Commercial Distribution

  • 50197106780297 ()
  • 10197106780299 ()
SEY41EPBHA

  • Ophthalmic surgical procedure kit, medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY40EPM13
In Commercial Distribution

  • 50197106733538 ()
  • 10197106733530 ()
SEY40EPM13

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY40EPMLE
In Commercial Distribution

  • 50197106733149 ()
  • 10197106733141 ()
SEY40EPMLE

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY48EYOE8
In Commercial Distribution

  • 50197106732210 ()
  • 10197106732212 ()
SEY48EYOE8

  • Ophthalmic surgical procedure kit, medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY48EYO10
In Commercial Distribution

  • 50197106777297 ()
  • 10197106777299 ()
SEY48EYO10

  • Ophthalmic surgical procedure kit, medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY53BSV13
In Commercial Distribution

  • 50197106797431 ()
  • 10197106797433 ()
SEY53BSV13

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEYOCEPVH6
In Commercial Distribution

  • 50197106810581 ()
  • 10197106810583 ()
SEYOCEPVH6

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEYDHEPFAC
In Commercial Distribution

  • 50197106805648 ()
  • 10197106805640 ()
SEYDHEPFAC

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY45EPCWE
In Commercial Distribution

  • 50197106801619 ()
  • 10197106801611 ()
SEY45EPCWE

  • Ophthalmic surgical procedure kit, medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY56EPOSA
In Commercial Distribution

  • 50197106806256 ()
  • 10197106806258 ()
SEY56EPOSA

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEYCGEPME2
In Commercial Distribution

  • 50197106626205 ()
  • 10197106626207 ()
SEYCGEPME2

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY23EPNVF
In Commercial Distribution

  • 50197106625048 ()
  • 10197106625040 ()
SEY23EPNVF

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY42EPWP4
In Commercial Distribution

  • 50197106626359 ()
  • 10197106626351 ()
SEY42EPWP4

  • Ophthalmic surgical procedure kit, medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY41EPS19
In Commercial Distribution

  • 50197106646524 ()
  • 10197106646526 ()
SEY41EPS19

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY3WEYJA9
In Commercial Distribution

  • 50197106645657 ()
  • 10197106645659 ()
SEY3WEYJA9

  • Ophthalmic surgical procedure kit, medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY11BSCHQ
In Commercial Distribution

  • 50197106640058 ()
  • 10197106640050 ()
SEY11BSCHQ

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEYCNEYCRW
In Commercial Distribution

  • 50197106634897 ()
  • 10197106634899 ()
SEYCNEYCRW

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY53EYS12
In Commercial Distribution

  • 50197106630981 ()
  • 10197106630983 ()
SEY53EYS12

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY69BS112
In Commercial Distribution

  • 50197106628070 ()
  • 10197106628072 ()
SEY69BS112

  • Ophthalmic surgical procedure kit, medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY13EPL15
In Commercial Distribution

  • 50197106632213 ()
  • 10197106632215 ()
SEY13EPL15

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY73EPBSA
In Commercial Distribution

  • 50197106629992 ()
  • 10197106629994 ()
SEY73EPBSA

  • Ophthalmic surgical procedure kit, medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY53BSV10
In Commercial Distribution

  • 50197106643295 ()
  • 10197106643297 ()
SEY53BSV10

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY45EYEAI
In Commercial Distribution

  • 50197106707317 ()
  • 10197106707319 ()
SEY45EYEAI

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY69EPVI6
In Commercial Distribution

  • 50197106692507 ()
  • 10197106692509 ()
SEY69EPVI6

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY53BSVTP
In Commercial Distribution

  • 50197106690374 ()
  • 10197106690376 ()
SEY53BSVTP

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY56EPCPA
In Commercial Distribution

  • 50197106689903 ()
  • 10197106689905 ()
SEY56EPCPA

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY41EPS20
In Commercial Distribution

  • 50197106689378 ()
  • 10197106689370 ()
SEY41EPS20

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY13EPL16
In Commercial Distribution

  • 50197106686070 ()
  • 10197106686072 ()
SEY13EPL16

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY40EPM12
In Commercial Distribution

  • 50197106702312 ()
  • 10197106702314 ()
SEY40EPM12

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY42EPWPK
In Commercial Distribution

  • 50197106700981 ()
  • 10197106700983 ()
SEY42EPWPK

  • Ophthalmic surgical procedure kit, medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY69BS115
In Commercial Distribution

  • 50197106693801 ()
  • 10197106693803 ()
SEY69BS115

  • Ophthalmic surgical procedure kit, medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY42EPWSF
In Commercial Distribution

  • 50197106685806 ()
  • 10197106685808 ()
SEY42EPWSF

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY63EYWPM
In Commercial Distribution

  • 50197106685684 ()
  • 10197106685686 ()
SEY63EYWPM

  • Ophthalmic surgical procedure kit, non-medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY22EPSCD
In Commercial Distribution

  • 50197106682560 ()
  • 10197106682562 ()
SEY22EPSCD

  • Ophthalmic surgical procedure kit, medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEY69BS114
In Commercial Distribution

  • 50197106680092 ()
  • 10197106680094 ()
SEY69BS114

  • Ophthalmic surgical procedure kit, medicated, single-use
EYE PACK
Cardinal Health 200, LLC
SEYCGEPME3
In Commercial Distribution

  • 50197106676903 ()
  • 10197106676905 ()
SEYCGEPME3

  • Ophthalmic surgical procedure kit, non-medicated, single-use
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