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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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ROYAL STRETCH - G296RS301300

(28"-30") rOYAL sTRETCH 3 pLY wOOL sMALL nO hOLE
Royal Knit, Inc.
RS3-0/1-30
In Commercial Distribution

  • G296RS301300 ()
RS3-0/1-30

  • Stump sock

actiTENS - B786SBM2AA1100

actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS Android app
In Commercial Distribution

  • B786SBM2AA1100 ()
SBM2AA110

  • Analgesic transcutaneous electrical nerve stimulation system

actiTENS - B786SBM1AB0110

The actiTENS electric impulse generator can be held on the patient's body thanks to a self-adhesive trip made of a silicone-based adhesive. The self-adhesive strip is intended to be placed on any part of the body but not on injured or irritated skin. The purpose of the self-adhesive strip is to maintain the actiTENS electric impulse generator near the part of the body which the patient wants to stimulate.
SUBLIMED
actiTENS self-adhesive strips
In Commercial Distribution

  • B786SBM1AB0110 ()
SBM1AB011

  • Analgesic transcutaneous electrical nerve stimulation system

actiTENS - B786SBM1AA1100

actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS
In Commercial Distribution

  • B786SBM1AA1100 ()
SBM1AA110

  • Analgesic transcutaneous electrical nerve stimulation system

actiTENS - B786SBM1AA0170

actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS standard kit
In Commercial Distribution

  • B786SBM1AA0170 ()
SBM1AA017

  • Analgesic transcutaneous electrical nerve stimulation system

ROYAL FLUSH - G296OBHRF302220

(20"-22") Royal Flush 3 Ply Black Heavy Small/Medium With Hole
Royal Knit, Inc.
OBHRF3-0/2-22
In Commercial Distribution

  • G296OBHRF302220 ()
OBHRF3-0/2-22

  • Stump sock

ROYAL FLUSH - G296OBHRF302140

(12"-14") Royal Flush 3 Ply Black Heavy Small/Medium With Hole
Royal Knit, Inc.
OBHRF3-0/2-14
In Commercial Distribution

  • G296OBHRF302140 ()
OBHRF3-0/2-14

  • Stump sock

ROYAL FLUSH - G296OBHRF302120

(10"-12") Royal Flush 3 Ply Black Heavy Small/Medium With Hole
Royal Knit, Inc.
OBHRF3-0/2-12
In Commercial Distribution

  • G296OBHRF302120 ()
OBHRF3-0/2-12

  • Stump sock

ROYAL FLUSH - G296OBHRF302100

(8"-10") Royal Flush 3 Ply Black Heavy Small/Medium With Hole
Royal Knit, Inc.
OBHRF3-0/2-10
In Commercial Distribution

  • G296OBHRF302100 ()
OBHRF3-0/2-10

  • Stump sock

ROYAL FLUSH - G296OBHRF301260

(24"-26") Royal Flush 3 Ply Black Heavy Small With Hole
Royal Knit, Inc.
OBHRF3-0/1-26
In Commercial Distribution

  • G296OBHRF301260 ()
OBHRF3-0/1-26

  • Stump sock
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