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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 Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
43526050 Polyaxial Pedicle Screw, Cannulated ø=6.0 L=50
In Commercial Distribution

  • 04719873023080 ()


  • Spinal bone screw, non-bioabsorbable
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
43526045 Polyaxial Pedicle Screw, Cannulated ø=6.0 L=45
In Commercial Distribution

  • 04719873023073 ()


  • Spinal bone screw, non-bioabsorbable
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
43526040 Polyaxial Pedicle Screw, Cannulated ø=6.0 L=40
In Commercial Distribution

  • 04719873023066 ()


  • Spinal bone screw, non-bioabsorbable
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
43526035 Polyaxial Pedicle Screw, Cannulated ø=6.0 L=35
In Commercial Distribution

  • 04719873023059 ()


  • Spinal bone screw, non-bioabsorbable
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
43526030 Polyaxial Pedicle Screw, Cannulated ø=6.0 L=30
In Commercial Distribution

  • 04719873023042 ()


  • Spinal bone screw, non-bioabsorbable
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
43515040 Polyaxial Pedicle Screw ø=5.0 L=40
In Commercial Distribution

  • 04719873022557 ()


  • Spinal bone screw, non-bioabsorbable
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
43515035 Polyaxial Pedicle Screw ø=5.0 L=35
In Commercial Distribution

  • 04719873022540 ()


  • Spinal bone screw, non-bioabsorbable
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
43515030 Polyaxial Pedicle Screw ø=5.0 L=30
In Commercial Distribution

  • 04719873022533 ()


  • Spinal bone screw, non-bioabsorbable
Light-curing Temporary Filling Material ; Spacer Yellow 3g x 1 syringe
VERICOM CO., LTD.
SP103-SY00
In Commercial Distribution

  • 08809254454513 ()


  • Temporary dental crown/bridge
Light curing individual tray resin; Eazipan LC Pink 2 sheet/ container
VERICOM CO., LTD.
EP402-S000
In Commercial Distribution

  • 08809254454476 ()
  • 08809254454506 ()


  • Dental impression tray material
Phosphoric etching gel ; DenFil Etchant-37 0.5ml x 1 syringe
VERICOM CO., LTD.
ET105-S000
In Commercial Distribution

  • 08809254454360 ()


  • Dental etching solution
Light-curing Temporary Filling Material ; Spacer Blue 3g x 1 syringe
VERICOM CO., LTD.
SP103-SB00
In Commercial Distribution

  • 08809254454322 ()


  • Temporary dental crown/bridge
Resin-base Pit and Fissure sealant ; Eco-S 0.5g x 1 syringe
VERICOM CO., LTD.
ES105-S000
In Commercial Distribution

  • 08809254454308 ()


  • Dental unfilled resin sealant
EDTA Root Canal Preparation Cream-Cleanser, Endodontic, Root Canal; Well-Prep 1g X 1syringe
VERICOM CO., LTD.
WE101-S000
In Commercial Distribution

  • 08809254454278 ()


  • Dental tooth-cleaning solution
Light-Cured Radiopaque Flowable Composite Resin ; DenFil Flow A2 0.5g x 1 syringe
VERICOM CO., LTD.
FR102-SA22
In Commercial Distribution

  • 08809254454100 ()


  • Dental composite resin
Resin-based dental restorative material; DenFil A3 1g x 1 syringe
VERICOM CO., LTD.
DF104-SA33
In Commercial Distribution

  • 08809254454018 ()


  • Dental composite resin
Resin-based dental restorative material ; DenFil A2 1g x 1 syringe
VERICOM CO., LTD.
DF104-SA22
In Commercial Distribution

  • 08809254454001 ()


  • Dental composite resin
Phosphoric etching gel ; DenFil Etchant-37 1.5g x 4 syringes
VERICOM CO., LTD.
ET148-K000
In Commercial Distribution

  • 08809254452434 ()


  • Dental etching solution
EDTA Root Canal Preparation Cream - Cleanser, Endodontic, Root Canal ; Well-Prep Blue 3g x 3 syringes
VERICOM CO., LTD.
WE109-K000
In Commercial Distribution

  • 08809254452236 ()


  • Dental tooth-cleaning solution
EDTA Root Canal Preparation Cream - Cleanser, Endodontic, Root Canal ; Well-Prep Blue 3g x 1 syringe
VERICOM CO., LTD.
WE103-KB00
In Commercial Distribution

  • 08809254452229 ()


  • Dental tooth-cleaning solution
EDTA Root Canal Preparation Cream - Cleanser, Endodontic, Root Canal ; Well-Prep 6g x 1 syringe
VERICOM CO., LTD.
WE106-K000
In Commercial Distribution

  • 08809254452212 ()


  • Dental tooth-cleaning solution
EDTA Root Canal Preparation Cream - Cleanser, Endodontic, Root Canal ; Well-Prep 6g x 3 syringes
VERICOM CO., LTD.
WE118-K000
In Commercial Distribution

  • 08809254452205 ()


  • Dental tooth-cleaning solution
EDTA Root Canal Preparation Cream-Cleanser, Endodontic, Root Canal; Well-Prep 6g X 1syringe
VERICOM CO., LTD.
WE106-K000
In Commercial Distribution

  • 08809254452199 ()


  • Dental tooth-cleaning solution
Light curing individual tray resin; Eazipan LC Pink 50 sheets/container
VERICOM CO., LTD.
EP450-K000
In Commercial Distribution

  • 08809254454476 ()
  • 08809254452076 ()


  • Dental impression tray material
5th generation Single Component Bonding Agent ; BC Plus 5ml x 1 bottle
VERICOM CO., LTD.
BP405-R000
In Commercial Distribution

  • 08809254451918 ()


  • Dentine bonding agent/set
5th generation Single Component Bonding Agent ; BC Plus 1ml x 1 bottle
VERICOM CO., LTD.
BP401-S000
In Commercial Distribution

  • 08809254451895 ()


  • Dentine bonding agent/set
Light-curing Temporary Filling Material ; Spacer Blue 3g x 3 syringes
VERICOM CO., LTD.
SP103-B000
In Commercial Distribution

  • 08809254451864 ()


  • Temporary dental crown/bridge
Light-curing Temporary Filling Material ; Spacer Yellow 3g x 3 syringes
VERICOM CO., LTD.
SP103-Y000
In Commercial Distribution

  • 08809254451857 ()


  • Temporary dental crown/bridge
Resin-base Pit and Fissure sealant ; Eco-S 1.2ml x 1 syringe
VERICOM CO., LTD.
ES105-R000
In Commercial Distribution

  • 08809254451826 ()


  • Dental unfilled resin sealant
Resin-base Pit and Fissure sealant ; Eco-S 1.2ml x 4 syringes
VERICOM CO., LTD.
ES105-RK00
In Commercial Distribution

  • 08809254451819 ()


  • Dental unfilled resin sealant
Resin-base Pit and Fissure sealant ; Eco-s 1.2ml x 2 syringes, DenFil Etchant-37 1.5g x 2 syringes
VERICOM CO., LTD.
ES105-K000
In Commercial Distribution

  • 08809254451802 ()


  • Dental unfilled resin sealant
  • Dental etching solution
Phosphoric etching gel ; DenFil Etchant-37 1.5g x 1 syringe
VERICOM CO., LTD.
ET101-EC00
In Commercial Distribution

  • 08809254451741 ()


  • Dental etching solution
Phosphoric etching gel ; DenFil Etchant-37 30ml x 1 syringe
VERICOM CO., LTD.
ET130-B000
In Commercial Distribution

  • 08809254451710 ()


  • Dental etching solution
Phosphoric etching gel ; DenFil Etchant-37 3ml x 12 syringes
VERICOM CO., LTD.
ET136-K000
In Commercial Distribution

  • 08809254451703 ()


  • Dental etching solution
Phosphoric etching gel ; DenFil Etchant-37 3ml x 1 syringe
VERICOM CO., LTD.
ET103-R000
In Commercial Distribution

  • 08809254451697 ()


  • Dental etching solution
Phosphoric etching gel ; DenFil Etchant-37 5ml x 1 syringe
VERICOM CO., LTD.
ET105-R000
In Commercial Distribution

  • 08809254451666 ()


  • Dental etching solution
Phosphoric etching gel ; DenFil Etchant-37 3ml x 5 syringes
VERICOM CO., LTD.
ET115-E000
In Commercial Distribution

  • 08809254451635 ()


  • Dental etching solution
Phosphoric etching gel ; DenFil Etchant-37 5ml x 5 syringes
VERICOM CO., LTD.
ET125-B000
In Commercial Distribution

  • 08809254451604 ()


  • Dental etching solution
Light-Cured Radiopaque Flowable Composite Resin ; DenFil Flow A3.5 2g x 4 syringes
VERICOM CO., LTD.
FR102-D000
In Commercial Distribution

  • 08809254451437 ()


  • Dental composite resin
Light-Cured Radiopaque Flowable Composite Resin ; DenFil Flow A3 2g x 4 syringes
VERICOM CO., LTD.
FR102-C000
In Commercial Distribution

  • 08809254451420 ()


  • Dental composite resin
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