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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Bite Block
ETHOX MEDICAL, LLC
950094201
In Commercial Distribution

  • 20889483150037 ()
  • 10889483150030 ()


  • Seizure bite block
Mouth Rest Thick
Specialized Care Company
OWDT
In Commercial Distribution

  • 00859938000206 ()
OWDT

  • Seizure bite block
Mouth Rest Regular
Specialized Care Company
OWD
In Commercial Distribution

  • 00859938000169 ()
OWD

  • Seizure bite block
No Description
MAXILL, INC.
6070541517
In Commercial Distribution

  • D89260705415170 ()
  • D89260705415171 ()


  • Seizure bite block
No Description
MAXILL, INC.
6070541515
In Commercial Distribution

  • D89260705415150 ()
  • D89260705415151 ()


  • Seizure bite block
No Description
MAXILL, INC.
6070541516
In Commercial Distribution

  • D89260705415160 ()
  • D89260705415161 ()


  • Seizure bite block
Bite Stick,Green, 10/pkg
AMERICAN DIAGNOSTIC CORP
4010T
In Commercial Distribution

  • 00634782501952 ()
  • 00634782001964 ()
4010T

  • Seizure bite block
No Description
FLEXICARE MEDICAL LIMITED
032-10-800U
In Commercial Distribution

  • 05055788710349 ()


  • Seizure bite block
MECTA ECT Cotton Bite Blocks Size Medium
SIGMASTIM DOMESTIC, LLC
9391-0003 M
In Commercial Distribution

  • 10850045508088 ()


  • Seizure bite block
MECTA ECT Cotton Bite Blocks Size Large
SIGMASTIM DOMESTIC, LLC
9391-0003 L
In Commercial Distribution

  • 10850045508071 ()


  • Seizure bite block
HEADMIRROR 3-1/2 IN X 1/2 IN
JEDMED INSTRUMENT COMPANY
48-0120
In Commercial Distribution

  • M6334801200 ()
48-0120

  • Head reflector
HEADMIRROR & HEADBAND COMPLETE
JEDMED INSTRUMENT COMPANY
48-0110
In Commercial Distribution

  • M6334801100 ()
48-0110

  • Head reflector
MIRROR DISPLAY FOR S-FRAME
SONTEC INSTRUMENTS, INC.
A-000.00.308
In Commercial Distribution

  • 00192896071186 ()
A-000.00.308

  • Head reflector
Disposable Bite Stick Bite Block/Tongue Depressor
TELEFLEX INCORPORATED
IPN041777
In Commercial Distribution

  • 24026704580228 ()
  • 04026704580224 ()
1174

  • Seizure bite block
BITE BLOCK,ADULT
MEDLINE INDUSTRIES, INC.
DYK1000BB
In Commercial Distribution

  • 40884389755731 ()
  • 10884389755730 ()
DYK1000BB

  • Seizure bite block
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755200429 ()
C-002.17.080

  • Head reflector
No Description
Heine Optotechnik GmbH & Co. KG
3,5 V Scale 2
In Commercial Distribution

  • 04053755120376 ()
C-001.35.015

  • Head reflector
No Description
Heine Optotechnik GmbH & Co. KG
3,5 V Scale 1
In Commercial Distribution

  • 04053755120345 ()
C-002.35.010

  • Head reflector
No Description
Heine Optotechnik GmbH & Co. KG
3,5 V
In Commercial Distribution

  • 04053755120109 ()
C-002.14.400

  • Head reflector
No Description
Heine Optotechnik GmbH & Co. KG
2,5 V Scale 2
In Commercial Distribution

  • 04053755120079 ()
C-001.35.015

  • Head reflector
No Description
Heine Optotechnik GmbH & Co. KG
2,5 V Scale 1
In Commercial Distribution

  • 04053755120055 ()
C-001.35.010

  • Head reflector
No Description
Heine Optotechnik GmbH & Co. KG
2,5 V
In Commercial Distribution

  • 04053755119943 ()
C-001.14.400

  • Head reflector
Adult Bite Block
BIOSEAL
19901/10
In Commercial Distribution

  • 10630094199013 ()
  • 00630094199016 ()


  • Seizure bite block
BITE BLOCK 3PCS ST
PENTAX OF AMERICA, INC.
KUMOF-Z5K
In Commercial Distribution

  • 04961333243426 ()
  • 14961333243423 ()


  • Seizure bite block
STANDARD BITE BLOCKS, 3 PIECES
PENTAX OF AMERICA, INC.
OF-Z5K
In Commercial Distribution

  • 04961333244171 ()
  • 14961333244178 ()


  • Seizure bite block
Integra® Miltex® Frankel Head Band and Mirror Set, Includes REF# 1-242 and 1-244
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-240
In Commercial Distribution

  • H83412400 ()
  • 10381780463047 ()
1-240

  • Head reflector
Integra® Miltex® Head Mirror, 3" Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-243
In Commercial Distribution

  • H83412430 ()
  • 10381780357643 ()
1-243

  • Head reflector
Head Mirror
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
1-242
In Commercial Distribution

  • H83412420 ()
  • 10381780357636 ()

  • 3-5/8" Outer Diameter
1-242

  • Head reflector
Seizure Bite Stick
GF HEALTH PRODUCTS, INC.
3789
In Commercial Distribution

  • M36837892 ()
  • M36837891 ()
  • M36837890 ()


  • Seizure bite block
Pack includes: Bareskin Ultra Ribbed Ecstasy Charged Her Pleasure Ecstasy
CHURCH & DWIGHT CO., INC.
00022600953036
In Commercial Distribution

  • 00022600953036 ()
  • 80022600953032 ()


  • Basic male condom, Hevea-latex
Pack includes: Ultra Thin Her Pleasure Ecstasy Ultra-Enz Comfort Thintensity
CHURCH & DWIGHT CO., INC.
00022600952978
In Commercial Distribution

  • 00022600952978 ()
  • 80022600952974 ()


  • Basic male condom, Hevea-latex
AIR STAIR ASSY NO MOD G 3-5 * (PLS) (WHEELCHAIR)
LIFEPORT, LLC
21-10040-01
In Commercial Distribution

  • 00810050862288 ()


  • Assistive automobile wheelchair/occupant lift
INSTALLATION, POWER LOADING SYSTEM, FALCON * PLS, WHEELCHAIR
LIFEPORT, LLC
21-10075-01
In Commercial Distribution

  • 00810050862172 ()


  • Assistive automobile wheelchair/occupant lift
INSTALLATION, RAIL ASSEMBLY, GLOBAL PLS * (WHEELCHAIR, PM)
LIFEPORT, LLC
21-10081-01
In Commercial Distribution

  • 00810050862035 ()


  • Assistive automobile wheelchair/occupant lift
Pack includes: Ultra Thin, Her Pleasure Ecstasy, Ultra ENZ and Thintensity.
CHURCH & DWIGHT CO., INC.
00022600001492
In Commercial Distribution

  • 00022600001492 ()
  • 80022600952974 ()


  • Basic male condom, Hevea-latex
The Computerized Dynamic Posturography (CDP ) system is a clinical balance assessment device that collects and analyzes force and moment data from a balance plate. The balance plate is seated in a dynamic chassis that can move in both translational and rotational directions, under control of the Balance Advantage (BA) software program. The BA software contains both assessment and training modules that can be used during each session. Assessments have set run-times during which they collect data after the “Start” button is pressed, while trainings have customizable run-times varying from 1 minute to 15 minutes. The system is intended to be used by trained clinicians in a hospital or clinical (physical therapy or ENT) environment who operate the software and ensure the safety of the patient. The patient being assessed on the system is placed in a harness. There are three different harness sizes with varying weight limits that can be purchase with the system; standard harness supports up to 300lbs, pediatric is up to 100lbs, and the bariatric supports up to 450lbs. The mechanical components of the system are designed to support up to 500lb patients.
BERTEC CORPORATION
97P-0036
In Commercial Distribution

  • 00850017250079 ()


  • Posturography system platform
Bertec Balance Advantage Prime IVR system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate with Immersive Virtual Reality (IVR) to enhance clinical balance assessment and training.
BERTEC CORPORATION
97P-0072
In Commercial Distribution

  • 00850017250062 ()


  • Posturography system platform
Bertec Balance Advantage Portable Essential system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
BERTEC CORPORATION
97P-0002
In Commercial Distribution

  • 00850017250055 ()


  • Posturography system platform
Bertec Balance Advantage Essential system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
BERTEC CORPORATION
97P-0001
In Commercial Distribution

  • 00850017250048 ()


  • Posturography system platform
Bertec Balance Advantage Functional system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
BERTEC CORPORATION
97P-0005
In Commercial Distribution

  • 00850017250031 ()


  • Posturography system platform
Bertec Balance Advantage Portable Functional system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
BERTEC CORPORATION
97P-0066
In Commercial Distribution

  • 00850017250024 ()


  • Posturography system platform
Bertec Balance Advantage Essential Spark system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
BERTEC CORPORATION
97P-0077
In Commercial Distribution

  • 00850017250017 ()


  • Posturography system platform
No Description
Balance Tracking Systems Incorporated
BTRACKS-50
In Commercial Distribution

  • 00860010129104 ()


  • Posturography system platform
Each ForcePlate consists of a sandwich of 2 uniform precision metal plates, with 4 load cells mounted between them. The vertical component of the total reaction force is measured independent of where it is applied over the surface of the plates. The relative light weight and small geometry of the plates aids in a wide range of upper and lower limb applications. The ForcePlates measure as little as the touch of a finger through to full standing weight bearing. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013.
BIOMETRICS LIMITED
FP3
In Commercial Distribution

  • 05060481690089 ()


  • Posturography system platform
No Description
VIRTUALIS
MOT
In Commercial Distribution

  • 03760310780562 ()


  • Posturography system platform
No Description
VIRTUALIS
V1
In Commercial Distribution

  • 03760310780555 ()


  • Posturography system platform
No Description
SORIN GROUP ITALIA SRL
PC
In Commercial Distribution

  • 38033178104792 ()
  • 08033178104791 ()


  • Centrifugal circulatory assist pump, electric
No Description
SORIN GROUP ITALIA SRL
REVOLUTION
In Commercial Distribution

  • 38033178104778 ()
  • 08033178104777 ()


  • Centrifugal circulatory assist pump, electric
SP PUMP HEAD ADAPTER
TERUMO CORPORATION
XX*SP03
In Commercial Distribution

  • 54987350734438 ()
  • 04987350734433 ()
XX*SP03

  • Centrifugal circulatory assist pump, electric
CAPIOX® SP PUMP
TERUMO CORPORATION
CX*SP45
In Commercial Distribution

  • 04987350706119 ()
  • 54987350706114 ()


  • Centrifugal circulatory assist pump, electric
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