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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AMALGAM CARRIERS M/L 2.8/3.4 mm outside Diameter
Power Dental U.S.A. Inc.
4309
In Commercial Distribution

  • D9434309 ()
4309

  • Surgical/emergency suction cannula, non-illuminating, reusable
  • Dental amalgam carrier
BONE / AMALGAM CARRIERS TITANIUM S/M 2.0/2.8 mm outside Diameter
Power Dental U.S.A. Inc.
4308T
In Commercial Distribution

  • D9434308T00 ()
4308T

  • Surgical/emergency suction cannula, non-illuminating, reusable
  • Dental amalgam carrier
AMALGAM CARRIERS S/M 2.0/2.8 mm outside Diameter
Power Dental U.S.A. Inc.
4308
In Commercial Distribution

  • D9434308 ()
4308

  • Surgical/emergency suction cannula, non-illuminating, reusable
  • Dental amalgam carrier
Kit Contains: R227 Explorer 23/Probe UNC-12 R518 CSS-3 Gold Line™ Composite Sculpting System R362 113 Off Angle Cord Packer
PDT, INC.
R909 - PDT Wallet 3 Pack - Doctor
In Commercial Distribution

  • 00813677025227 ()
R909

  • Dental surgical probe, reusable
  • Dental spatula, reusable
  • Gingival retraction cord packing tool
Iowa State Fixation Forceps, Flat Handle With Polished Finish, Straight Shafts, 1 X 2 Teeth, And Overall Length Of 3 3/8" (86mm)
Med Saver, Inc.
5-2835
In Commercial Distribution

  • 00194613006624 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220515 ()


  • Indirect flat panel x-ray detector
AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220508 ()


  • Indirect flat panel x-ray detector
AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220492 ()


  • Indirect flat panel x-ray detector
Reusable surgical instrument used during pelvic fixation procedure to convert a flexible intramedullary implant to a rigid state in order to stabilize and repair a bone fracture.
Curvafix Inc
CLA-001
In Commercial Distribution

  • 10855068008423 ()
CLA-001

  • Surgical screwdriver, reusable
Reusable surgical instrument used during pelvic fixation procedure to convert a flexible intramedullary implant to a rigid state in order to stabilize and repair a bone fracture.
Curvafix Inc
CSA-001
In Commercial Distribution

  • 10855068008409 ()
CSA-001

  • Surgical screwdriver, reusable
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