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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Single use, premium study kit with two XXlarge ReadyRip Belts
Cleveland Medical Devices Inc.
Two Belt - XXLarge
In Commercial Distribution

  • B14360201282 ()
  • B14360201261 ()
  • B14360201272 ()
602-0123

  • Electroencephalograph
Single use, premium study kit with two large ReadyRip Belts
Cleveland Medical Devices Inc.
Two Belt - Large
In Commercial Distribution

  • B14360201222 ()
  • B14360201201 ()
  • B14360201212 ()
602-0120

  • Electroencephalograph
Single use, premium study kit extra extra large.
Cleveland Medical Devices Inc.
Extra Extra Large - Single
In Commercial Distribution

  • B14360201141 ()
  • B14360201162 ()
  • B14360201152 ()
602-0114

  • Electroencephalograph
Single use, premium study kit extra large.
Cleveland Medical Devices Inc.
Extra Large - Single
In Commercial Distribution

  • B14360201111 ()
  • B14360201132 ()
  • B14360201122 ()
602-0111

  • Electroencephalograph
Single use, premium study kit large.
Cleveland Medical Devices Inc.
Large - Single
In Commercial Distribution

  • B14360201081 ()
  • B14360201102 ()
  • B14360201092 ()
602-0108

  • Electroencephalograph
Single use study kit (compatible with thermistor).
Cleveland Medical Devices Inc.
Compatible with Thermistor - Single
In Commercial Distribution

  • B14360200761 ()
  • B14360200772 ()
  • B14360200782 ()
602-0076

  • Electroencephalograph
Sterile Thumb Forcep
MOLDED PRODUCTS, INC.
MPC-3000
In Commercial Distribution

  • B144MPC30002 ()
  • B144MPC30000 ()
  • B144MPC30003 ()
MPC-3000

  • Surgical soft-tissue manipulation forceps, tweezers-like, single-use
Sterile Disposable Tube Occluding Forcep
MOLDED PRODUCTS, INC.
MPC-200BS
In Commercial Distribution

  • B144MPC200BS1 ()
  • B144MPC200BS0 ()
  • B144MPC200BS3 ()
MPC-200BS

  • Medical tubing clip/clamp, temporary, non-calibrated, single-use
Single use, premium study kit with two Xlarge ReadyRip Belts
Cleveland Medical Devices Inc.
Two Belt - XLarge
In Commercial Distribution

  • B14360201252 ()
  • B14360201231 ()
  • B14360201242 ()
602-0123

  • Electroencephalograph
Single use, proact premium study kit.
Cleveland Medical Devices Inc.
Proact - Single
In Commercial Distribution

  • B14360200791 ()
  • B14360200812 ()
  • B14360200802 ()
602-0079

  • Electroencephalograph
No Description
Cleveland Medical Devices Inc.
Single
In Commercial Distribution

  • B14360200751 ()
  • B14360200692 ()
  • B14360200682 ()
602-0075

  • Electroencephalograph
Single use, extra extra large respiratory belt.
Cleveland Medical Devices Inc.
Extra Extra Large - Single
In Commercial Distribution

  • B143502020450 ()
  • B14360201051 ()
  • B14360201021 ()
502-0204-5

  • Electroencephalograph
Single use, extra large respiratory belt.
Cleveland Medical Devices Inc.
Extra Large - Single
In Commercial Distribution

  • B143502020440 ()
  • B14360201041 ()
  • B14360201011 ()
502-0204-4

  • Electroencephalograph
Single use, large respiratory belt.
Cleveland Medical Devices Inc.
Large - Single
In Commercial Distribution

  • B143502020430 ()
  • B14360201031 ()
  • B14360201001 ()
502-0204-3

  • Electroencephalograph
Single use, medium respiratory belt.
Cleveland Medical Devices Inc.
Medium - Single
In Commercial Distribution

  • B143502020420 ()
  • B14360201311 ()
  • B14360201301 ()
502-0204-2

  • Electroencephalograph
Micro Applicators Fine (1.5mm) Mauve
Bright Supply, Inc.
BSI-1500
In Commercial Distribution

  • D974BSI15000 ()
  • D974BSI15001 ()
  • D974BSI15002 ()
  • D974BSI15003 ()


  • Dental material application tool, single-use
Micro Applicators Superfine (1.0mm) White
Bright Supply, Inc.
BSI-1000
In Commercial Distribution

  • D974BSI10002 ()
  • D974BSI10001 ()
  • D974BSI10003 ()
  • D974BSI10000 ()


  • Dental material application tool, single-use
Cotton Tipped applicator 6" small tip.
Bright Supply, Inc.
BSI-0006
In Commercial Distribution

  • D974BSI00062 ()
  • D974BSI00060 ()
  • D974BSI00061 ()
  • D974BSI00063 ()


  • General-purpose absorbent tip applicator/swab, single-use
Cotton Tipped applicator 3" small tip.
Bright Supply, Inc.
BSI-0003
In Commercial Distribution

  • D974BSI00032 ()
  • D974BSI00031 ()
  • D974BSI00030 ()
  • D974BSI00033 ()


  • General-purpose absorbent tip applicator/swab, single-use
Orthodontic appliance system, progressive FDA PT: HJDC
Digital Orthodontic Care
Aligners
In Commercial Distribution

  • D918SCA2 ()
  • D918SCA1 ()
  • D918SCA0 ()


  • Orthodontic progressive aligner
Gelling fiber wound dressing, 4"x4"
IMBED BIOSCIENCES, INC
91002
Not in Commercial Distribution

  • B519910022 ()
  • B519910021 ()
  • B519910020 ()

  • Area/Surface Area: 16 Square inch
91002

  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Gelling fiber wound dressing, 2" x 2"
IMBED BIOSCIENCES, INC
91001
Not in Commercial Distribution

  • B519910012 ()
  • B519910011 ()
  • B519910010 ()

  • Area/Surface Area: 4 Square inch
91001

  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
The !SEN-Goggles are used in the assessment of nystagmus by measuring, recording, displaying, and analyzing eye movements. This device consists of patient eye goggles ("ISEN-Goggles"). They have an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USS port to facilitate transfer of data captured and stored in the device's SD-type memory. The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for near-simultaneous viewing of the video images from both eyes on the attached LCD screen.
ISEN Tech. & Trading Co.,Ltd.
V06
In Commercial Distribution

  • B499V062 ()
  • B499V061 ()
  • B499V060 ()


  • Nystagmus inducing optokinetic drum
  • Nystagmus inducing tape
Vitale Cover Dressings, 6" x 6", 30/box, 10 boxes/case
CELLERA LLC
24506
In Commercial Distribution

  • B492245062 ()
  • B492245061 ()
  • B492245060 ()
24506

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Cover Dressings, 4" x 4", 30/box, 8 boxes/case
CELLERA LLC
24504
In Commercial Distribution

  • B492245042 ()
  • B492245041 ()
  • B492245040 ()
24504

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Cover Dressings, 2" x 2", 30/box, 8 boxes/case
CELLERA LLC
24502
In Commercial Distribution

  • B492245022 ()
  • B492245021 ()
  • B492245020 ()
24502

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Vitale Hydrogel Dressing, 4"x4", 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
23844
In Commercial Distribution

  • B492238440 ()
  • B492238441 ()
  • B492238442 ()
23844

  • Wound hydrogel dressing, non-antimicrobial
Vitale Hydrogel Impregnated Dressing, 2x2, 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
23822
In Commercial Distribution

  • B492238222 ()
  • B492238221 ()
  • B492238220 ()
23822

  • Wound hydrogel dressing, non-antimicrobial
Vitale Sacral Hydrocolloid Dressing, 6x7, 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
21290
In Commercial Distribution

  • B492212900 ()
  • B492212901 ()
  • B492212902 ()
21290

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Vitale Hydrocolloid Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
21244
In Commercial Distribution

  • B492212442 ()
  • B492212441 ()
  • B492212440 ()
21244

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Vitale Hydrocolloid Dressings, 2" x 2", 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
21222
In Commercial Distribution

  • B492212222 ()
  • B492212221 ()
  • B492212220 ()
21222

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Vitale Thin Hydrocolloid Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
21044
Not in Commercial Distribution

  • B492210442 ()
  • B492210441 ()
  • B492210440 ()
21044

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Vitale Hydroconductive Dressings, 4" x 5", 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
20845
In Commercial Distribution

  • B492208452 ()
  • B492208451 ()
  • B492208450 ()
20845

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Vitale Hydroconductive Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
20844
In Commercial Distribution

  • B492208442 ()
  • B492208441 ()
  • B492208440 ()
20844

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Vitale Hydroconductive Dressings, 2" x 2", 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
20822
In Commercial Distribution

  • B492208222 ()
  • B492208221 ()
  • B492208220 ()
20822

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Vitale Hydroconductive Ropes, 1/pouch, 5/box, 10 boxes/case
CELLERA LLC
20800
In Commercial Distribution

  • B492208002 ()
  • B492208001 ()
  • B492208000 ()
20800

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Vitale Calcium Alginate Dressings, 4" x 5", 10/box, 10 boxes/case
CELLERA LLC
20645
In Commercial Distribution

  • B492206452 ()
  • B492206451 ()
  • B492206450 ()
20645

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Vitale Calcium Alginate Dressings, 4" x 4", 10/box, 10 boxes/case
CELLERA LLC
20644
In Commercial Distribution

  • B492206442 ()
  • B492206441 ()
  • B492206440 ()
20644

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Vitale Calcium Alginate Dressings, 2" x 2", 10/box, 10 boxes/case
CELLERA LLC
20622
In Commercial Distribution

  • B492206222 ()
  • B492206221 ()
  • B492206220 ()
20622

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Vitale Calcium Alginate Ropes, 5/box, 10 boxes/case
CELLERA LLC
20600
In Commercial Distribution

  • B492206002 ()
  • B492206001 ()
  • B492206000 ()
20600

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
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