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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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Power Dental USA - D9432320

HATCHET TGF 13L L-DOWN CUT, IN/OUT SHAPE, AT 2 O'CLOCK, for Duggan Institute
Power Dental U.S.A. Inc.
2320
In Commercial Distribution

  • D9432320 ()
2320

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe

wtATTR-CM AcceleraTTR™ - 05415062388310

Software to identify heart failure patients who may be at risk of having wtATTR-CM
PFIZER INC.
CI4054279
In Commercial Distribution

  • 05415062388310 ()


  • Cardiovascular interpretive screening software

LightForce X - 00854103007295

Infrared phototherapy device emitting up to 10 W at 810/980 nm, 7" display
LITECURE LLC
LTC-1001-L-B6
In Commercial Distribution

  • 00854103007295 ()


  • Musculoskeletal/physical therapy laser, professional

SoLa Therapy Laser - 00854103007066

Infrared phototherapy device emitting up to 8W at 810/980nm, battery option, 10" display
LITECURE LLC
LTC-1510-SOLA
In Commercial Distribution

  • 00854103007066 ()


  • Musculoskeletal/physical therapy laser, professional

VMS Left Posterior Aiming Device (Re-Use) - 06009712290413

VMS Left Posterior Aiming Device (Re-Use): Used to score the femoral neck at 45°.
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD14
In Commercial Distribution

  • 06009712290413 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

VMS Right Posterior Aiming Device (Re-Use) - 06009712290406

VMS Right Posterior Aiming Device (Re-Use): Used to score the femoral neck at 45°.
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD13
In Commercial Distribution

  • 06009712290406 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

VMS Left Anterior Aiming Device (Re-Use) - 06009712290390

VMS Left Anterior Aiming Device (Re-Use): Used to score the femoral neck at 45°
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD12
In Commercial Distribution

  • 06009712290390 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

VMS Right Anterior Aiming Device (Re-Use) - 06009712290383

VMS Right Anterior Aiming Device (Re-Use): Used to score the femoral neck at 45°.
ELITE SURGICAL SUPPLIES (PTY) LTD
VMSAD11
In Commercial Distribution

  • 06009712290383 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Bone Molder - Straight - 00083208130120

Bone molder - used to compress bone in between dental Implants at time of placement
Suncoast Dental, Inc
Bone Molder - Straight
In Commercial Distribution

  • 00083208130120 ()
Bone Molder - Straight

  • Osteotomy compression/distraction instrument

Surgical Direct - B382SD883331000

5mm 32cm Strong Forceps, Fenestrated, Serrated, Oval-Shaped Jaw that Converge at Distal End, Double
Surgical Direct, Inc.
SD88333.100
In Commercial Distribution

  • B382SD883331000 ()
SD88333.100

  • Laparoscopic tissue manipulation forceps/working-channel
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