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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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REAL Immersive System - 00815948024229

REAL i-Series
PENUMBRA, INC.
RLE1-A
In Commercial Distribution

  • 00815948024229 ()


  • Mental health/function therapeutic software, virtual reality
  • Mindfulness/behavioural therapy software, non-clinician-consultative

TeleRehab Software Work Station/Seat License - 00856298006251

The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow monitoring and recording of electrocardiograph (ECG) rhythm strips and related information for patients undergoing an exercise therapy program. Patients are monitored by medical telemetry exercise monitoring equipment. This feature allows patients to comply with exercise prescriptions while exercising at a medical/rehabilitation facility near their home, or by returning to the primary medical facility to participate in an in-house cardiopulmonary rehabilitation program. VersaCare includes a Program Management module that prints a variety of reports.
SCOTTCARE CORPORATION, THE
TeleRehab Software Work Station/Seat License
In Commercial Distribution

  • 00856298006251 ()
101608

  • Electrocardiography telemetric monitoring system

ALFIS-3 - 08806133010136

FLUOROMETER FOR CLINICAL USE
Boditech Med Inc.
FPRR028
In Commercial Distribution

  • 08806133010136 ()
FPRR028

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
  • Fluorescent immunoassay analyser IVD, laboratory

OsteoMed - 00845694068048

.035" x 4" Double Trocar K-wire Sterile Qty 5
OSTEOMED LLC
316-0119-SP-05
In Commercial Distribution

  • 00845694068048 ()

  • Outer Diameter: 0.035 Inch
316-0119-SP-05

  • Craniofacial fixation plate kit, non-bioabsorbable

OsteoMed - 00845694068024

.062" x 6" Double Trocar K-wire Sterile Qty 5
OSTEOMED LLC
316-0118-SP-05
In Commercial Distribution

  • 00845694068024 ()

  • Outer Diameter: 0.062 Inch
316-0118-SP-05

  • Craniofacial fixation plate kit, non-bioabsorbable

OsteoMed - 00845694068000

.035" x 6" Double Trocar K-wire Sterile Qty 5
OSTEOMED LLC
316-0117-SP-05
In Commercial Distribution

  • 00845694068000 ()

  • Outer Diameter: 0.035 Inch
316-0117-SP-05

  • Craniofacial fixation plate kit, non-bioabsorbable

OsteoMed - 00845694067980

Cannulated 1.7mm Drill, Long, Manual Sterile Qty 2
OSTEOMED LLC
316-0116-SP-02
In Commercial Distribution

  • 00845694067980 ()
316-0116-SP-02

  • Craniofacial fixation plate kit, non-bioabsorbable

OsteoMed - 00845694067966

.035 x 4" Partially Threaded K-wire Sterile Qty 5
OSTEOMED LLC
316-0114-SP-05
In Commercial Distribution

  • 00845694067966 ()

  • Outer Diameter: 0.035 Inch
316-0114-SP-05

  • Craniofacial fixation plate kit, non-bioabsorbable

OsteoMed - 00845694067942

.035" x 4" K-wire Sterile Qty 5
OSTEOMED LLC
316-0107-SP-05
In Commercial Distribution

  • 00845694067942 ()

  • Outer Diameter: 0.035 Inch
316-0107-SP-05

  • Craniofacial fixation plate kit, non-bioabsorbable

OsteoMed - 00845694067928

.035" x 6" K-wire Sterile Qty 2
OSTEOMED LLC
316-0106-SP-02
In Commercial Distribution

  • 00845694067928 ()

  • Outer Diameter: 0.035 Inch
316-0106-SP-02

  • Craniofacial fixation plate kit, non-bioabsorbable
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