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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reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Demo Version provides demonstration access to various prescription versions of the reSET product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008200 ()


  • Mental health/function therapeutic software, screen-viewed
ROI-C IMPLANT 12X15.5 H5
LDR Spine Usa, Inc.
MC1351P
In Commercial Distribution

  • 03662663016346 ()

  • Width: 15.5 Millimeter
  • Depth: 12 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
ROI-C IMPLANT 12X14 H5
LDR Spine Usa, Inc.
MC1341P
In Commercial Distribution

  • 03662663016278 ()

  • Width: 14 Millimeter
  • Depth: 12 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
ROI-C IMPLANT 14X17 H5
LDR Spine Usa, Inc.
MC1331P
In Commercial Distribution

  • 03662663016209 ()

  • Width: 17 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
ROI-C IMPLANT 14X15.5 H5
LDR Spine Usa, Inc.
MC1321P
In Commercial Distribution

  • 03662663016131 ()

  • Width: 15.5 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
ROI-C IMPLANT 14X14 H5
LDR Spine Usa, Inc.
MC1311P
In Commercial Distribution

  • 03662663016063 ()

  • Width: 14 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
LIGATURE DIRECTOR/ #H5 HOLLOW
J & J INSTRUMENTS INC
77-819
In Commercial Distribution

  • 00817524029468 ()


  • Orthodontic ligature director
SCALER #H5/33 HOLLOW
J & J INSTRUMENTS INC
71-533
In Commercial Distribution

  • 00817524029178 ()


  • Manual dental scaler, reusable
SCALER TOWNER-JACQUETTE, #H5/33
BMT Medizintechnik GmbH
719-125
In Commercial Distribution

  • 04251725202170 ()
719-125

  • Bone curette, reusable
PLUGGER 2.7mm/SCALER H5
Power Dental U.S.A. Inc.
5898
In Commercial Distribution

  • D94358980 ()
5898

  • Manual dental scaler, reusable
  • Dental excavator, reusable
#H5/GF21S SCALER DE
HU-FRIEDY MFG. CO., LLC
SC1393
In Commercial Distribution

  • 10889950091187 ()


  • Manual dental scaler, reusable
#H5/U15 DE Scaler
HU-FRIEDY MFG. CO., LLC
SH5/U15
In Commercial Distribution

  • 10889950028275 ()


  • Manual dental scaler, reusable
#H5/33 DE Scaler
HU-FRIEDY MFG. CO., LLC
SH5/33
In Commercial Distribution

  • 10889950028183 ()


  • Manual dental scaler, reusable
Dull Scaler H5/L4
HU-FRIEDY MFG. CO., LLC
DSH5/L46
In Commercial Distribution

  • 10889950106171 ()


  • Manual dental scaler, reusable
#H5/NEB128 Scaler EE2
HU-FRIEDY MFG. CO., LLC
SC6691E2
In Commercial Distribution

  • 10889950103323 ()


  • Periodontal curette
SCALERS JACQUETTE H5/33
Power Dental U.S.A. Inc.
1203
In Commercial Distribution

  • D94312030 ()
1203

  • Dental excavator, reusable
  • Manual dental scaler, reusable
SCALERS TOWNER H5/U15
Power Dental U.S.A. Inc.
1202
In Commercial Distribution

  • D94312020 ()
1202

  • Dental excavator, reusable
  • Manual dental scaler, reusable
Acclean Scaler H5/Langer
HENRY SCHEIN, INC.
5703776
In Commercial Distribution

  • 00304040184899 ()
5703776

  • Manual dental scaler, reusable
Dental Scaler H5/5
Surgical Direct, Inc.
SD1229
In Commercial Distribution

  • B382SD12290 ()
SD1229

  • Dental elevator, tooth/root
Safco Scaler, H5/33
NORDENT MANUFACTURING INC
102-9916
In Commercial Distribution

  • 00840018600805 ()


  • Manual dental scaler, reusable
SE SCALER #5 (H5)
NORDENT MANUFACTURING INC
SCN5
In Commercial Distribution

  • 00840018610736 ()


  • Manual dental scaler, reusable
No Description
OXOS Medical, Inc.
APP
In Commercial Distribution

  • 00860008892744 ()


  • Hand-held basic diagnostic x-ray system, digital
OVO IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impression, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. OVO IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
3D IMAGING AND SIMULATION CORP. AMERICAS
IOS-FP-71-003
In Commercial Distribution

  • 00864206000437 ()


  • Dental milling system, CAD/CAM, chairside
Heron IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Heron IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
3D IMAGING AND SIMULATION CORP. AMERICAS
IOS-FP-71-001
In Commercial Distribution

  • 00864206000406 ()


  • Dental milling system, CAD/CAM, chairside
No Description
Great Lakes Neurotechnologies Inc.
700-0026
In Commercial Distribution

  • 00859584006102 ()
700-0026

  • Tremor transducer
VeriPulse IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Veripulse IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
WHIP-MIX CORPORATION
70675
Not in Commercial Distribution

  • D040706751 ()


  • Dental milling system, CAD/CAM, chairside
Vscan Air for iOS
GE Vingmed Ultrasound AS
Air for iOS
In Commercial Distribution

  • 00840682147071 ()


  • Ultrasound imaging system application software
WVSM Management Suite - iOS
ATHENA GTX, INC.
iOS Software
In Commercial Distribution

  • B3943950006000 ()
395-0006-00

  • Centralized patient monitor
SEER 1000 IOS APPLICATION
Ge Medical Systems Information Technologies, Inc.
1000 IOS Application
In Commercial Distribution

  • 00840682116879 ()


  • Electrocardiographic ambulatory recorder
DreamMapper iOS China Instance
Respironics, Inc.
DreamMapper iOS, China Instance - 2
Not in Commercial Distribution

  • 00606959057722 ()
1136968

  • Self-care monitoring/reporting software
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