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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TouchGuides are made from a thin, clear polycarbonate material and precisely engineered to help guide the user’s touch to targeted icons on the screen and reduce accidental activations. TouchGuides allow the Accent 1000 to be set up to accommodate a wide range of cognitive and motor skills. Using the TouchGuide with the 1000 requires the device frame that came with the 1000.
PRENTKE ROMICH COMPANY
17344-28
In Commercial Distribution

  • 00858526006262 ()


  • Voice synthesizer/digitizer
The keyguard allows the Accent 1400 to be set up for specific locations to accommodate a wide range of cognitive and motor skills. Using the keyguard with the 1400 requires the device frame that came with the 1400. If a replacement frame is needed please go to 1400 Device Frame.
PRENTKE ROMICH COMPANY
17342-28
In Commercial Distribution

  • 00858526006194 ()


  • Voice synthesizer/digitizer
TouchGuides are made from clear polycarbonate material and precisely engineered to help guide the user’s touch to targeted icons on the screen and reduce accidental activations. TouchGuides allow the Accent 1400 to be set up to accommodate a wide range of cognitive and motor skills. Using the TouchGuide with the 1400 requires the device frame that came with the 1400. If a replacement frame is needed please go to 1400 Device Frame.
PRENTKE ROMICH COMPANY
17341-28
In Commercial Distribution

  • 00858526006088 ()


  • Voice synthesizer/digitizer
No Description
MEDIVATORS INC.
ML02-0127
In Commercial Distribution

  • 30677964054267 ()
  • 00677964054266 ()


  • Medical device disinfection agent
No Description
CAPTIVA SPINE, INC.
PS2816
In Commercial Distribution

  • M739PS28160 ()


  • Polymeric spinal interbody fusion cage
No Description
CAPTIVA SPINE, INC.
PS2815
In Commercial Distribution

  • M739PS28150 ()


  • Polymeric spinal interbody fusion cage
No Description
CAPTIVA SPINE, INC.
PS2814
In Commercial Distribution

  • M739PS28140 ()


  • Polymeric spinal interbody fusion cage
No Description
CAPTIVA SPINE, INC.
PS2813
In Commercial Distribution

  • M739PS28130 ()


  • Polymeric spinal interbody fusion cage
No Description
CAPTIVA SPINE, INC.
PS2812
In Commercial Distribution

  • M739PS28120 ()


  • Polymeric spinal interbody fusion cage
No Description
CAPTIVA SPINE, INC.
PS2811
In Commercial Distribution

  • M739PS28110 ()


  • Polymeric spinal interbody fusion cage
No Description
CAPTIVA SPINE, INC.
PS2810
In Commercial Distribution

  • M739PS28100 ()


  • Polymeric spinal interbody fusion cage
No Description
CAPTIVA SPINE, INC.
PS2809
In Commercial Distribution

  • M739PS28090 ()


  • Polymeric spinal interbody fusion cage
No Description
CAPTIVA SPINE, INC.
PS2808
In Commercial Distribution

  • M739PS28080 ()


  • Polymeric spinal interbody fusion cage
No Description
CAPTIVA SPINE, INC.
FPT2814
In Commercial Distribution

  • M739FPT28140 ()


  • Spinal implant trial
No Description
CAPTIVA SPINE, INC.
FPT2813
In Commercial Distribution

  • M739FPT28130 ()


  • Spinal implant trial
No Description
CAPTIVA SPINE, INC.
FPT2812
In Commercial Distribution

  • M739FPT28120 ()


  • Spinal implant trial
No Description
CAPTIVA SPINE, INC.
FPT2811
In Commercial Distribution

  • M739FPT28110 ()


  • Spinal implant trial
No Description
CAPTIVA SPINE, INC.
FPT2810
In Commercial Distribution

  • M739FPT28100 ()


  • Spinal implant trial
No Description
CAPTIVA SPINE, INC.
FPT2809
In Commercial Distribution

  • M739FPT28090 ()


  • Spinal implant trial
No Description
CAPTIVA SPINE, INC.
FPT2808
In Commercial Distribution

  • M739FPT28080 ()


  • Spinal implant trial
No Description
CAPTIVA SPINE, INC.
FPT2807
In Commercial Distribution

  • M739FPT28070 ()


  • Spinal implant trial
No Description
Eckert & Ziegler BEBIG GmbH
LAH02-28#03
Not in Commercial Distribution

  • 04049223106669 ()
LAH02-28

  • General-purpose brachytherapy system applicator, remote-afterloading
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
217464
In Commercial Distribution

  • 03661489174643 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Dynarex Corporation
36279
In Commercial Distribution

  • 00840117323346 ()
  • 00840117315419 ()
  • 00840117315327 ()


  • Nasopharyngeal airway, single-use
No Description
Bird & Cronin, LLC
08142669
In Commercial Distribution

  • 00610570010554 ()


  • Knee sling
No Description
Bird & Cronin, LLC
08148213
In Commercial Distribution

  • 00610570187379 ()
  • 00610570127559 ()


  • Urinary catheter holder
Valproic Acid - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10322218
Not in Commercial Distribution

  • 00630414527338 ()
  • 00630414027647 ()
5258292

  • Valproic acid therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Valproic Acid - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10322215
Not in Commercial Distribution

  • 00630414527321 ()
5256877

  • Valproic acid therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
This is a medical device.This is a medical device.
KaVo Dental GmbH
0.571.6741
In Commercial Distribution

  • EKAV057167410 ()
micro Tip No 28

  • Ultrasonic dental scaling/debridement system
Rapicide OPA 28 Minimum Required Concentration (MRC) Test Strip
MEDIVATORS INC.
ML02-0136
In Commercial Distribution

  • 30677964100957 ()
  • 10677964100953 ()
  • 00677964100956 ()
ML020136

  • Medical device disinfection solution test strip
DENTAL PORCELAIN POWDER FOR CREATING DENTAL RESTORATIONS
CHAMELEON DENTAL PRODUCTS, INC
FPA128
In Commercial Distribution

  • FPA128 ()


  • Dental porcelain/ceramic restoration kit
Advocate Lancets Safety 28 Gauge 1.8 mm box of 200, sterile, for capillary blood sample, needle automatically retracts, ready to use, no loading needed, single use only
DIABETIC SUPPLY OF SUNCOAST, INC.
637
In Commercial Distribution

  • 10894046001919 ()
  • 00894046001912 ()
  • 20894046001916 ()


  • Manual blood lancing device, single-use
Rapicide OPA 28 Test Strips for verifying the Concentration of RAPICIDE OPA-28 High-Level Disinfectant. (Crosstex)
MEDIVATORS INC.
ML02-0137
In Commercial Distribution

  • 00732224000541 ()
  • 10732224000548 ()
ML020137

  • Medical device disinfection solution test strip
Workstation Microsoft Surface Studio 28 for Zirkonzahn Scanner
ZIRKONZAHN SRL
SYAB0510
In Commercial Distribution

  • D800SYAB0510 ()


  • Dental milling system, CAD/CAM, laboratory
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
REDAX SPA
21828
In Commercial Distribution

  • 18034139293797 ()
  • 08034139293790 ()
21828

  • Pleural catheter
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
REDAX SPA
20828
In Commercial Distribution

  • 18034139292851 ()
  • 08034139292854 ()
20828

  • Pleural catheter
No Description
Ventana Medical Systems, Inc.
05251621001
In Commercial Distribution

  • 07613336125571 ()
05251621001

  • Assay container IVD, single-use
No Description
BIOPRO, INC.
14091
In Commercial Distribution

  • M209140910 ()


  • Press-fit hip femur prosthesis, modular
No Description
BIOPRO, INC.
14090
In Commercial Distribution

  • M209140900 ()


  • Press-fit hip femur prosthesis, modular
No Description
BIOPRO, INC.
14089
In Commercial Distribution

  • M209140890 ()


  • Press-fit hip femur prosthesis, modular
No Description
PEARSON DENTAL SUPPLIES, INC.
C660035
In Commercial Distribution

  • D724C6600351 ()


  • Dental composite resin
A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4240-4228
In Commercial Distribution

  • 09421028119962 ()
4240-4228

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Biomet Orthopedics, LLC
31-433508
In Commercial Distribution

  • 00880304312098 ()

  • 10° Hi-Wall 28 mm Size 28
31-433508

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
31-423508
In Commercial Distribution

  • 00880304310810 ()

  • 10° 28 mm Liner Size 28
31-423508

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
31-105888
In Commercial Distribution

  • 00880304301412 ()

  • SIZE 28, ACETABULAR LINER 28 MM
31-105888

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
31-433708
In Commercial Distribution

  • 00887868258749 ()

  • Hi-Wall +5 28 mm Size 28
31-433708

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
33-116828
In Commercial Distribution

  • 00887868502279 ()

  • Size 28 X 28 mm I.D.
33-116828

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
33-115828
In Commercial Distribution

  • 00887868502040 ()

  • Size 28 X 28 mm I.D.
33-115828

  • Acetabulum prosthesis trial, prefabricated, reusable
Ultra Seal Low Ring Locking Liner Size 28
Alps South, LLC
USLSL28
In Commercial Distribution

  • 00713980036111 ()


  • External limb prosthesis socket liner
Ultra Seal High Ring Locking Liner Size 28
Alps South, LLC
USHSL28
In Commercial Distribution

  • 00713980036005 ()


  • External limb prosthesis socket liner
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