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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DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 60CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO60
In Commercial Distribution

  • 10852528005206 ()

  • Intro Sheath 4 Fr
  • Max OD 0.053 inches
  • High Speed 140 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • guidewire size OD 0.012 inches
  • Shaft Length 60 cm
  • Nose Length 7 mm
  • Crown Size 1.25 mm
  • Crown Type, Micro
7-10001

  • Mechanical atherectomy system catheter, peripheral
No Description
ergoline GmbH
705780
In Commercial Distribution

  • 04059358001470 ()


  • Bicycle ergometer
VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, complete
icotec AG
42-700
In Commercial Distribution

  • 07640172552438 ()
42-700

  • Device sterilization/disinfection container, reusable
No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
44-000302
In Commercial Distribution

  • 10841307118275 ()
44-000302

  • Dental implant suprastructure, permanent, preformed
No Description
ALYK, INC.
Personal Lubricant - .COM
In Commercial Distribution

  • 00851617007872 ()


  • General-body orifice lubricant, non-sterile
No Description
MICROPORT CRM SRL
V3.10 USB COM
In Commercial Distribution

  • 08031527014296 ()


  • Electrocardiographic long-term ambulatory recording analyser
Non sterile single use OR table drape with forced-air warming and safe patient positioning capabilities.
BCG MEDICAL, LLC
OSA90X39SUP
In Commercial Distribution

  • 00868680000310 ()
  • 10868680000317 ()
OSA90X39SUP

  • External circulating-air core temperature regulation system pad, single-use
Non sterile single use OR table drape with warm air circulating and safe patient positioning capabilities.
BCG MEDICAL, LLC
OSA96X39LIT
In Commercial Distribution

  • 10868680000300 ()
  • 00868680000303 ()
  • 20868680000307 ()
OSA96X39LIT

  • External circulating-air core temperature regulation system pad, single-use
No Description
Natus Medical Denmark ApS
1096, PC CLINICAL COM US
In Commercial Distribution

  • 05713315005589 ()
8-04-16034

  • Impedance audiometer
No Description
Natus Medical Denmark ApS
1096, PC, DIAGNOSTIC, COM, US
In Commercial Distribution

  • 05713315005558 ()
8-04-16031

  • Impedance audiometer
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