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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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The Macy Catheter is intended to provide rectal access to administer liquids/medications.
HOSPI CORPORATION
E
In Commercial Distribution

  • 00861003000202 ()
MAC-1001

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
Cylindrical tip dedicated to drill and widen the access canal to schneiderian membrane
SATELEC
TIP TKW3 II
In Commercial Distribution

  • 03609820875330 ()
F87533

  • Dental ultrasonic surgical system handpiece tip
Cylindrical tip dedicated to drill and widen the access canal to schneiderian membrane
SATELEC
TIP TKW3
In Commercial Distribution

  • 03609820873336 ()
F87333

  • Dental ultrasonic surgical system handpiece tip
The Monopolar Hook is a single-use sterile electrosurgical electrode for use with the HandXTM device. The Monopolar Hook is connected to the HandX device and transmits the HandX device motors’ rotation in order to articulate the movement of the end effector of the Monopolar Hook. It is designed to address surgeons’ needs relating to the application of monopolar diathermy for various surgical purposes. The Monopolar Hook is connected to a standard electrosurgical unit via a standard generator cable.
HUMAN XTENSIONS LTD
20-30-044-01
In Commercial Distribution

  • 07290017376080 ()
  • 17290017376087 ()
20-30-073-01

  • Endoscopic electrosurgical electrode, monopolar, single-use
The Uterine Sound is used to gauge the depth and position of the uterine cavity. It is also helpful with the placement of IUDs and the verification of the intrauterine position and length for HSG procedures. The proximal portion of the sound is 3.5 mm in diameter tapering to 2.5 mm at the distal portion with a bulbous tip to reduce the risk of perforation. Malleable to adapt to anatomical variations.It is a sterile, disposable, single-use only device.
PANPAC MEDICAL CORPORATION
BA100
In Commercial Distribution

  • 04715309122037 ()
  • 04715309125250 ()


  • Uterine sound, single-use
No Description
EBM TECHNOLOGIES INCORPORATED
MobiPACS™ App
In Commercial Distribution

  • 04719878879965 ()


  • Radiological PACS software
myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App Android
In Commercial Distribution

  • 09413000126273 ()


  • Electronic goniometer/kinesiology sensor
myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App iOS
In Commercial Distribution

  • 09413000126259 ()


  • Electronic goniometer/kinesiology sensor
No Description
Phillips-Medisize A/S
Android (Mobile App)
Not in Commercial Distribution

  • 05713495000060 ()
84601063

  • Medication reminder application software
No Description
Phillips-Medisize A/S
iOS (Mobile App)
Not in Commercial Distribution

  • 05713495000053 ()
84601063

  • Medication reminder application software
No Description
EMPATICA SRL
EpiMonitor App Android
In Commercial Distribution

  • 00853858006386 ()


  • Home seizure monitoring system
No Description
EMPATICA SRL
EpiMonitor App iOS
In Commercial Distribution

  • 00853858006379 ()


  • Home seizure monitoring system
No Description
EMPATICA SRL
Care App iOS
In Commercial Distribution

  • 00853858006249 ()


  • Multiple vital physiological parameter monitoring system, home-use
Healgen (DrugConfirm) - 10 Panel Cup Test: AMP1000/mAMP1000/BAR300/BZO300/COC300/MTD300/MDMA500/MOP2000/OXY100/PCP25
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP31-6104
In Commercial Distribution

  • 00856464008386 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Benzodiazepine group IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Methadone IVD, reagent
D9.17-1VF- COC300 OPI2000 AMP1000 MET1000 BAR300 BZO300 MDMA500 MTD300 PCP25
BTNX Inc
D9.17-1VF
In Commercial Distribution

  • 00722066008096 ()
  • 10722066008093 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel One Step DOA cup - (10.32) - COC300 MET1000 AMP1000 OPI2000 OXY100 MTD300 PCP25 BAR300 BZO300 MDMA500
BTNX Inc
D10.32-1VF
In Commercial Distribution

  • 00722066007945 ()
  • 10722066007942 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Drug Test Panel (8.25) AMP1000 BAR300 BZO300 COC300 MET1000 OPI2000 PCP25 THC50. For the detection of drugs in human urine. 25 tests/kit.
BTNX Inc
D8.25-1P29-25
In Commercial Distribution

  • 00722066005651 ()
  • 10722066005658 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 10 Panel Dip Card - BAR300/BUP10/BZO300/COC300/mAMP1000/MTD300/MOP2000/OXY100/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-7104
In Commercial Distribution

  • 00895330002820 ()


  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Nortriptyline IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
One Step 10 Panel DOA Cup (10.32) - COC300 MET1000 AMP1000 OPI2000 OXY100 MTD300 PCP25 BAR300 BZO300 MDMA500
BTNX Inc
D10.32-1V
In Commercial Distribution

  • 00722066005088 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-BCEM168NCPOS
In Commercial Distribution

  • 05712821013767 ()
CAS-BCEM168NCPOS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
AS-BCEM168NCPOS
In Commercial Distribution

  • 05712821013750 ()
AS-BCEM168NCPOS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-SBXM1606POS
In Commercial Distribution

  • 05712821013316 ()
CAS-SBXM1606POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-SBOM1608POS
In Commercial Distribution

  • 05712821012234 ()
CAS-SBOM1608POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-NBRM2010POS
In Commercial Distribution

  • 05712821012210 ()
CAS-NBRM2010POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-NBRM1808POS
In Commercial Distribution

  • 05712821012203 ()
CAS-NBRM1808POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-NBAM207POS
In Commercial Distribution

  • 05712821012197 ()
CAS-NBAM207POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-NBAM168POS
In Commercial Distribution

  • 05712821012180 ()
CAS-NBAM168POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-NBAM1407POS
In Commercial Distribution

  • 05712821012173 ()
CAS-NBAM1407POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-BRAM257POS
In Commercial Distribution

  • 05712821012104 ()
CAS-BRAM257POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-BRAM207POS
In Commercial Distribution

  • 05712821012098 ()
CAS-BRAM207POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-BRAM167POS
In Commercial Distribution

  • 05712821012081 ()
CAS-BRAM167POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-ATOM2010POS
In Commercial Distribution

  • 05712821012050 ()
CAS-ATOM2010POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-ATOM168POS
In Commercial Distribution

  • 05712821012043 ()
CAS-ATOM168POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-ATOM148POS
In Commercial Distribution

  • 05712821012036 ()
CAS-ATOM148POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-ATEM208POS
In Commercial Distribution

  • 05712821012029 ()
CAS-ATEM208POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-ATEM188POS
In Commercial Distribution

  • 05712821012012 ()
CAS-ATEM188POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-ATEM168POS
In Commercial Distribution

  • 05712821012005 ()
CAS-ATEM168POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
CAS-ATEM148POS
In Commercial Distribution

  • 05712821011992 ()
CAS-ATEM148POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
AS-SBXM1606POS
In Commercial Distribution

  • 05712821011282 ()
AS-SBXM1606POS

  • Dental prosthesis/implant abutment screw
The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.
Elos Medtech Pinol A/S
AS-NGMM1610POS
In Commercial Distribution

  • 05712821010513 ()
AS-NGMM1610POS

  • Dental prosthesis/implant abutment screw
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