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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A battery-powered device designed to be used by single trained operator to transport a hospital bed with steerable wheels with or without an occupant in a controlled manner within a hospital or associated environment. It typically consists of a chassis, batteries, an operator handle with operating panel, a bed gripping claw, electric motors that power the drive wheels, a remote control for operation/steering, brakes, and an emergency stop button. The device is attached (locked) to one end of the bed and pushes the bed, or pulls the bed after it. It is compatible for transport in lifts and for long and short internal transports.
STAMINALIFT INTERNATIONAL LIMITED
TS5000
In Commercial Distribution

  • B232TS50000 ()
STM450

  • Bed transporter
"Tetrax balance assessment is used to quantitatively detect changes in postural responses that have been shown to be indicative of the presence of a disturbance or pathology that affects balance and posture. It is used for the assessment of fall risk and as an aid in the diagnosis of a number of conditions that affect balance. The device designed in tour different modifications: Tetrax system contains platform and railing and Tetrax Free Plates that includes only 2 balance plates. The Tetrax provides valuable information concerning the functioning of neuro-physiological centers of postural control. This information assists the physician in confirming clinical impressions or suspicions. It helps to focus tests prescribed for the patient, and, more important, limits unnecessary tests, especially in cases of dizziness, vertigo, tiredness, and many other balance disorders or pathologies. The Tetrax system offers the possibility of evaluating the effects of therapeutic interventions in such cases. The system is capable of providing the physician with a comprehensive assessment of postural control and therefore may be used to assess accident proneness due to fatigue, stress, and/or intoxication. The Tetrax system provides valuable information on the effectiveness of prosthetic devices, including prostheses, splints, corsets, etc. Tetrax has wide application in the field of child psychology and developmental pediatrics and can be used in children for detecting neuro-physiological sources of insufficient school readiness, learning disabilities, dyslexia, Attention Deficit Disorders (ADD), etc. The Tetrax device includes a balance platform with a USB connector and software supplied on a CD for installation on a standard PC or an Omnisense device. The Tetrax balance platform is a platform that includes four separate plates. The subject stands on the platform, with each heel and toe-part on one of the four plates, guided by a foot-shaped sketch on each of the plates. Within
BEAMMED LTD
PLATFORM FORCE-MEASURING
Not in Commercial Distribution

  • 72990012704126 ()


  • Bone absorptiometric ultrasound system
No Description
Gulden Ophthalmics Inc.
1
In Commercial Distribution

  • B091151330 ()


  • Ophthalmic binocular gauge
Site~Rite 8 Ultrasound System Console (Remanufactured)
Bard Access Systems, Inc.
9770600Y
In Commercial Distribution

  • 00801741138287 ()
9770600Y

  • Ultrasound imaging system operator console
"Omnisense 7000: The Sunlight Omnisense Ultrasound Bone Sonometer is a non-invasive ultrasound device capable of measuring bone speed of sound (SOS) at one or more skeletal sites. It is comprised of a Main Unit and small hand held probes, each designed to measure SOS at one or more specific skeletal sites. The basic system is offered with one probe, capable of measuring SOS of the distal one-third radius and the mid-shaft tibia. Reference databases are provided for measurements at each of the skeletal sites. Omnisense measures SOS utilizing a technology based on well established laws of physics applied to the transmission of signals along the bone. The measurements are performed while the subject and the operator are comfortably seated. Results are expressed in meters per second (m/sec), reflecting the upper 95th percentile of the sorted SOS values. Omnisense reports the bone SOS, together with the T-score (units of standard deviations relative to population reference values of healthy young adults), Z-score values (units of standard deviations relative to age and gender matched population reference values), and patient risk assessment, computed using the patient's SOS value and a reference database. For any two measured skeletal sites, Omnisense may report the Osteoporosis, Risk Index (ORI™), which combines the individual results into a single clinical index. No calibration is required. Daily system verification is accomplished using the System Quality Verification (SQV) phantom supplied with the device. Probes: Omnisense is a multiple skeletal sites. The probes designed to support measurement at the following areas: • CM probe - used for bone strength assessment at the radius and tibia • CS probe - used for bone strength assessment at the phalanx • CR probe - used for bone strength assessment at the metatarsal The probes can be supplied with Omnisense 7000 and/or Omnisense 8000. Omnisense models: S – Adult application P – Pediatric application Premier - Premature
BEAMMED LTD
OMNISENSE 7000 ULTRASOUND BONE SONOMETER
Not in Commercial Distribution

  • 07299012704119 ()


  • Bone absorptiometric ultrasound system
"Sunlight MiniOmni: The Sunlight MiniOmni Ultrasound Bone Sonometer is a non-invasive ultrasound device capable of measuring bone speed of sound (SOS) at one or more skeletal sites. Sunlight MiniOmni Ultrasound Bone Sonometer is a modified version of company's well- established Sunlight Omnisense systems*. Sunlight MiniOmni is based on the Sunlight Omnipath™ technology already CE marked and approved by the FDA (PMA). It is comprised of a Main Unit and the same hand held probes as used with other BeamMed's Bone Sonometers, each designed to measure SOS at one or more specific skeletal sites. The basic system is offered with one probe, capable of measuring SOS of the distal one-third radius and the mid-shaft tibia. Reference databases are provided for measurements at each of the skeletal sites, Sunlight MiniOmni measures SOS utilizing a technology based on well- established laws of physics applied to the transmission of signals along the bone. The measurements are performed while the subject and the operator are comfortably seated. Results are expressed in meters per second (m/sec), reflecting the upper 95th percentile of the sorted SOS values. Sunlight MiniOmni reports the bone SOS, together with the Z-score (units of standard deviations relative to age and gender matched population reference values), for adults also as a T-score values (units of standard deviations relative to population reference values of healthy young adults), and patient risk assessment, computed using the patient's SOS value and a reference database. For any two measured skeletal sites, Sunlight No calibration is required. Daily system verification is accomplished using the System Quality Verification (SQV) phantom supplied with the device. Probes: MiniOmni is a multiple skeletal sites. The probes designed to support measurement at the following areas: • CM probes - used for bone strength assessment at the radius and tibia • CS probe - used for bone strength assessment at the phalanx • CR
BEAMMED LTD
Sunlight MiniOmni Ultrasound Bone Sonometer
In Commercial Distribution

  • 07290012704109 ()


  • Bone absorptiometric ultrasound system
CODMAN CERTAS X-Ray Overlay Tool
Medos International Sàrl
82-8859
Not in Commercial Distribution

  • 20886704078651 ()
  • 10886704078654 ()
828859

  • Cerebrospinal fluid shunt valve programmer
Medical parallel transport bed
Xiamen Weiyou Intelligent Technology Co.,Ltd
XW-PTB-8S
In Commercial Distribution

  • 06971234479655 ()


  • Bed transporter
TOOL 45809 STRATAVARIUS ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
45809
In Commercial Distribution

  • 00763000266981 ()


  • Cerebrospinal fluid shunt valve programmer
KIT 45806 STRATA VARIUS
MEDTRONIC PS MEDICAL, INC.
45806
In Commercial Distribution

  • 00763000266974 ()


  • Cerebrospinal fluid shunt valve programmer
TOOL 45809 STRATAVARIUS ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
45809
In Commercial Distribution

  • 00763000292553 ()


  • Cerebrospinal fluid shunt valve programmer
KIT 45806 STRATA VARIUS
MEDTRONIC PS MEDICAL, INC.
45806
In Commercial Distribution

  • 00763000292546 ()


  • Cerebrospinal fluid shunt valve programmer
KIT 45805 FP STRATA 2 ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
45805
In Commercial Distribution

  • 00763000281274 ()


  • Cerebrospinal fluid shunt valve programmer
CARD 45807 SMART STRATA
MEDTRONIC PS MEDICAL, INC.
45807
In Commercial Distribution

  • 00763000351410 ()


  • Cerebrospinal fluid shunt valve programmer
GUIDER SET 45910SMR ADJUST TOOL
MEDTRONIC PS MEDICAL, INC.
45910SMR
In Commercial Distribution

  • 00763000067588 ()


  • Cerebrospinal fluid shunt valve programmer
FULL SET 45909SMR STRATAMR ADJUST TOOL
MEDTRONIC PS MEDICAL, INC.
45909SMR
In Commercial Distribution

  • 00763000067571 ()


  • Cerebrospinal fluid shunt valve programmer
TOOL 45809 STRATAVARIUS ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
45809
In Commercial Distribution

  • 00885074467795 ()


  • Cerebrospinal fluid shunt valve programmer
KIT 45805 FP STRATA 2 ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
45805
In Commercial Distribution

  • 00885074219417 ()


  • Cerebrospinal fluid shunt valve programmer
TOOL 27826 STRATA II ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
27826
In Commercial Distribution

  • 00885074217130 ()


  • Cerebrospinal fluid shunt valve programmer
CARD 45808 SMART STRATA NSC
MEDTRONIC PS MEDICAL, INC.
45808
In Commercial Distribution

  • 00885074204598 ()


  • Cerebrospinal fluid shunt valve programmer
CARD 45807 SMART STRATA
MEDTRONIC PS MEDICAL, INC.
45807
In Commercial Distribution

  • 00885074204574 ()


  • Cerebrospinal fluid shunt valve programmer
Sterile Labels - General Liquids, 10 labels per panel, 1 panel per pouch, 100 pouches per Box
KEY SURGICAL, INC.
SL-100
Not in Commercial Distribution

  • 00849771043942 ()
  • 00849771033172 ()
  • 00849771033189 ()
SL100

  • Procedural medication labelling set
Sterile Labels - General Liquids, 10 labels per panel, 1 panel per pouch, 100 packages per box
KEY SURGICAL, INC.
SL100
In Commercial Distribution

  • 50849771050662 ()
  • 10849771050664 ()
  • 00849771050667 ()
  • 00849771033172 ()
SL100

  • Procedural medication labelling set
Sterile Labels - Custom CAME017, 10 labels per panel, 1 panel per pouch, 100 packages per box
KEY SURGICAL, INC.
SL118
In Commercial Distribution

  • 20849771039994 ()
  • 10849771039997 ()
  • 00849771039990 ()
SL118

  • Procedural medication labelling set
12 Panel Preview Panel,AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
PRE-WDOA-6124
In Commercial Distribution

  • 00816862021707 ()
  • 00816862021691 ()
  • 10816862021704 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
LabPro V5.0 Panel Update 10 (US), Electronic - C90679; DVD, LabPro V5.0 Panel Update 10 (US) - C90680
Beckman Coulter, Inc.
V5.00
In Commercial Distribution

  • 15099590772741 ()
  • 15099590772758 ()
C90679, C90680

  • Microorganism identification/antimicrobial-susceptibility analyser IVD
PANEL 235 128MM X 79MM X .025
MEDTRONIC PS MEDICAL, INC.
235
In Commercial Distribution

  • 00673978014562 ()

  • Width: 79.0 Millimeter
  • Height: 0.6 Millimeter
  • Length: 128.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ePlex Respiratory Panel Kit, 12 test, IVD
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005030 ()
EA001012

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
3 mode small panel light therapy device
Biophotas, Inc.
Series 2 RESTORE C/US
In Commercial Distribution

  • 00850523007730 ()
CLR2-001

  • Blue/red/infrared phototherapy lamp
3 mode large panel light therapy device
Biophotas, Inc.
Series 2 PRO C/US
In Commercial Distribution

  • 00850523007716 ()
CLP2-001

  • Blue/red/infrared phototherapy lamp
2 mode small panel light therapy device
Biophotas, Inc.
Series 2 HOME C/US
In Commercial Distribution

  • 00850523007747 ()
CPM2-001

  • Blue/red/infrared phototherapy lamp
4 mode small panel light therapy device
Biophotas, Inc.
Series 2 LITE C/US
In Commercial Distribution

  • 00850523007723 ()
CML2-001

  • Blue/red/infrared phototherapy lamp
4 mode large panel light therapy device
Biophotas, Inc.
Series 2 PRO PLUS C/US
In Commercial Distribution

  • 00850523007709 ()
CPM2-001

  • Blue/red/infrared phototherapy lamp
PANEL 235 128MM X 79MM X .025
MEDTRONIC PS MEDICAL, INC.
235
In Commercial Distribution

  • 00643169620674 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-200 CRANIAL MESH 200 X 200MM
MEDTRONIC PS MEDICAL, INC.
016-200
In Commercial Distribution

  • 00643169620650 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-128 CRANIAL MESH 128 X 79MM
MEDTRONIC PS MEDICAL, INC.
016-128
In Commercial Distribution

  • 00643169620636 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Drug Cup 13 Panel Plus AD Test
Prabadin Corp
PR48Y5-CUP
In Commercial Distribution

  • 10850051158086 ()
  • 00850051158089 ()
  • 00850051158102 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 016-152 CRANIAL MESH 152 X 152MM
MEDTRONIC PS MEDICAL, INC.
016-152
In Commercial Distribution

  • 00643169620643 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-120 CRANIAL MESH 120 X 120MM
MEDTRONIC PS MEDICAL, INC.
016-120
In Commercial Distribution

  • 00643169620629 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-100 CRANIAL MESH 100 X 100MM
MEDTRONIC PS MEDICAL, INC.
016-100
In Commercial Distribution

  • 00643169620612 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Fiber Optic Light Panel 4 inches 10.2CM
STERIS CORPORATION
88-1006K
In Commercial Distribution

  • 20885403285377 ()
  • 10885403285370 ()
881006K

  • Open surgical site internal light
Fiber Optic Light Panel 5 inches 12.7CM
STERIS CORPORATION
88-1005K
In Commercial Distribution

  • 20885403285360 ()
  • 10885403285363 ()
881005K

  • Open surgical site internal light
Fiber Optic Light Panel 6 inches 15.2CM
STERIS CORPORATION
88-1004K
In Commercial Distribution

  • 20885403285353 ()
  • 10885403285356 ()
881004K

  • Open surgical site internal light
Visual-ICE™ MRI Mobile Connection Panel Spare
BOSTON SCIENTIFIC CORPORATION
H74939700S71000
In Commercial Distribution

  • 00191506039752 ()
H74939700S71000

  • General cryosurgical system, cryogen gas, electronic
Medical Grade, HD Flat Panel Monitor, 32"
BR Surgical, LLC
BR900-4432
In Commercial Distribution

  • 00840183526917 ()
BR900-4432

  • Image display unit, colour
u-Card BZO Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-BZO-114L
In Commercial Distribution

  • 20817038021402 ()
  • 10817038021405 ()
  • 00817038021408 ()
U-BZO-114L

  • Benzodiazepine group IVD, kit, rapid ICT, clinical
u-Card BAR Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-BAR-114L
In Commercial Distribution

  • 20817038021396 ()
  • 10817038021399 ()
  • 00817038021392 ()
U-BAR-114L

  • Barbiturate IVD, kit, rapid ICT, clinical
u-Card MDMA Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-MDMA-114L
In Commercial Distribution

  • 20817038021389 ()
  • 10817038021382 ()
  • 00817038021385 ()
U-MDMA-114L

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
u-Card COC Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-COC-114L
In Commercial Distribution

  • 10817038021375 ()
  • 00817038021378 ()
  • 20817038021372 ()
U-COC-114L

  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
OPI 2000 Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-OPI-114
In Commercial Distribution

  • 20817038020474 ()
  • 10817038020477 ()
  • 00817038020470 ()
U-OPI-114

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
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