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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"HighLite" with comfortable headband transformer & charger, with mobile
Spiggle & Theis Medizintechnik GmbH
10-122-00
In Commercial Distribution

  • 04053755180318 ()
10-122-00

  • Head-worn fibreoptic light
Monitor with DOX SPO2, NIBP, HR with Bluetooth
CRITICARE TECHNOLOGIES, INC.
eQuality 506DNB
In Commercial Distribution

  • D438506DNBUS0 ()


  • Multiple vital physiological parameter monitoring system, clinical
bayonet with screws, serrated with thorns, 15.5 cm
Spiggle & Theis Medizintechnik GmbH
20-720-14
In Commercial Distribution

  • 04250381855744 ()
20-720-14

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
REMstar SE with Humidifier, with SD Slot, US
Respironics, Inc.
REMstar SE Auto with Humidifier, with SD Slot, US
Not in Commercial Distribution

  • 00606959012493 ()
DS220HS

  • Home CPAP unit
  • Heated respiratory humidifier
DreamStation, CPAP with Humidifier, with Heated Tube, Canada
Respironics, Inc.
DreamStation CPAP w/Humidifier, w/Heated Tube, CA
In Commercial Distribution

  • 00606959026544 ()
CAX200T12

  • Home CPAP unit
DreamStation CPAP with Humidifier, with Heated Tube, International
Respironics, Inc.
DreamStation CPAP w/Humidifier, w/Heated Tube, INTL
In Commercial Distribution

  • 00606959025837 ()
INX200T15

  • Home CPAP unit
DreamStation CPAP with Humidifier, with Heated Tube, USA
Respironics, Inc.
DreamStation CPAP w/Humidifier, w/Heated Tube, US
In Commercial Distribution

  • 00606959022379 ()
DSX200T11

  • Home CPAP unit
ZoomStar® with Trulight Colposcope with USB Video
Coopersurgical, Inc.
906057-40TU
In Commercial Distribution

  • 00888937013719 ()


  • Colposcope
ZoomScope® with Trulight Colposcope with 5-legged base
Coopersurgical, Inc.
906043-SP-5
In Commercial Distribution

  • 00888937013689 ()


  • Colposcope
ZoomScope® with Trulight Colposcope with 4-legged base
Coopersurgical, Inc.
906043-SP-4
In Commercial Distribution

  • 00888937013672 ()


  • Colposcope
ZoomScope® with Trulight Colposcope with 3-legged base
Coopersurgical, Inc.
906043-SP-3
In Commercial Distribution

  • 00888937013665 ()


  • Colposcope
Smart Outlet with bed pad with remote reset
Smart Caregiver Corporation
433SBW1-SYS
In Commercial Distribution

  • 00812293013779 ()


  • Bed/chair occupant movement pressure/vibration sensor
Smart Outlet with bed pad with remote reset
Smart Caregiver Corporation
433SBR1-SYS
In Commercial Distribution

  • 00812293011959 ()


  • Bed/chair occupant movement pressure/vibration sensor
Blood Pressure Monitor with standard cuff with Bluetooth
Masena Invest B.V.
BPM-2244sBT
In Commercial Distribution

  • 08719481720742 ()


  • Intermittent electronic patient thermometer
Stellaris PC with Laser with Version 4+ Software
Bausch & Lomb Incorporated
BL14304
In Commercial Distribution

  • 00757770520251 ()
BL14304

  • Phacoemulsification/vitrectomy system
Stellaris PC with Laser with Version 4+ Software
Bausch & Lomb Incorporated
BL14304
Not in Commercial Distribution

  • 00757770519897 ()
BL14304

  • Phacoemulsification/vitrectomy system
Vented IV Set with 72" Line with Chamber
ARGON MEDICAL DEVICES, INC.
039830000A
Not in Commercial Distribution

  • 20886333200775 ()
  • 00886333200771 ()

  • 72"
039830000A

  • Fluid transfer set, general-purpose
Laparoscopy / Pelviscopy Drape with Underleg Wings with Adhesive
O&M HALYARD, INC.
41379
In Commercial Distribution

  • 30680651413797 ()
  • 90680651413799 ()
41379NS

  • Patient surgical drape, single-use
ELVAREX 2/GLOVE TO ELBOW/WITH FINGER, WITH THUMB/SLIP FORM WITH VOLANT/BLACK
BSN-Jobst GmbH
77359-00017-00
In Commercial Distribution

  • 04019702303001 ()

  • Pressure 23-32 mmHg
77359-00017-00

  • Compression/pressure sock/stocking, reusable
ELVAREX 2/GLOVE TO ELBOW/WITH FINGER, WITH THUMB/SLIP FORM WITH VOLANT/CARAMEL
BSN-Jobst GmbH
77359-00043-00
In Commercial Distribution

  • 04019702302745 ()

  • Pressure 23-32 mmHg
77359-00043-00

  • Compression/pressure sock/stocking, reusable
Elvarex 2/Arm sleeve to axilla with glove, one piece/With Finger, with Thumb
BSN-Jobst GmbH
77360-00004-00
In Commercial Distribution

  • 04019702339000 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Glove to elbow/With Finger, with Thumb/Slip form with volant/Honey
BSN-Jobst GmbH
77359-00125-00
In Commercial Distribution

  • 04019702529340 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
5mm 45cm Maryland Dissector, with Diamond Serrations with with Non- Locking Reinforced, Carbon Fiber
Surgical Direct, Inc.
SD14128-53
In Commercial Distribution

  • B382SD14128530 ()
SD14128-53

  • Flexible endoscopic tissue manipulation forceps, single-use
Closed Suction Catheter, 10Fr, Elbow Tracheostomy, 24 Hour, with Caps, with 22mm Flex Adapter, with HME adapter, with Trach Wedge
Twin Med, LLC
1005592
In Commercial Distribution

  • 30840330703483 ()
  • 10840330703489 ()
  • 50840330703487 ()
  • 70840330703481 ()

  • Catheter Gauge: 10 French
  • Catheter Inner Diameter: 3.3 Millimeter
  • Length: 40.5 Centimeter
1005592

  • Airway suction catheter
Closed Suction Catheter, 8Fr, Elbow Tracheostomy, 24 Hour, with Caps, with 22mm Flex Adapter, with HME adapter, with Trach Wedge
Twin Med, LLC
1005591
In Commercial Distribution

  • 30840330703476 ()
  • 10840330703472 ()
  • 50840330703470 ()
  • 70840330703474 ()

  • Catheter Gauge: 8 French
  • Catheter Inner Diameter: 2.6 Millimeter
  • Length: 30.5 Centimeter
1005591

  • Airway suction catheter
CloudCover (disposable 5 pcs with system - labeled bag)
NEOLIGHT LLC
NL-SK-5
Not in Commercial Distribution

  • 10852788008092 ()
  • 10852788008139 ()


  • Blanket/pad infant phototherapy unit
Irrigation Tray with Piston Syringe
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
URHT19
In Commercial Distribution

  • 10850005165047 ()
  • 00850005165040 ()

  • Irrigation Tray with Piston Syringe
URHT19

  • Wound irrigation kit, non-sterile
Irrigation Tray with Bulb Syringe
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
URHT18
In Commercial Distribution

  • 10850005165030 ()
  • 00850005165033 ()

  • Irrigation Tray with Bulb Syringe
URHT18

  • Wound irrigation kit, non-sterile
Flange fixture ST 3mm w. BAHA abutment
Cochlear Bone Anchored Solutions AB
90480
In Commercial Distribution

  • 09321502014298 ()

  • Length: 3 Millimeter
  • Flange fixture 3mm with abutment
90480

  • Craniofacial bone screw, non-bioabsorbable
Widening drill 3 mm with countersink
Cochlear Bone Anchored Solutions AB
92140
In Commercial Distribution

  • 09321502019613 ()

  • Length: 3 Millimeter
  • Drill 3 mm with countersink
92140

  • General external orthopaedic fixation system implantation kit, reusable
Widening drill 4 mm with countersink
Cochlear Bone Anchored Solutions AB
92141
In Commercial Distribution

  • 09321502019620 ()

  • Length: 4 Millimeter
  • Drill 4 mm with countersink
92141

  • General external orthopaedic fixation system implantation kit, reusable
BIA400 Implant 4mm w abutment 14mm
Cochlear Bone Anchored Solutions AB
93338
In Commercial Distribution

  • 09321502033442 ()

  • Length: 14 Millimeter
  • Implant 4 mm with abutment
93338

  • Craniofacial bone screw, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
414848
In Commercial Distribution

  • 00880304369986 ()

  • 6MM X 150MM / WITH FLANGE
414848

  • Elbow ulna prosthesis trial
No Description
Biomet Orthopedics, LLC
414847
In Commercial Distribution

  • 00880304369979 ()

  • 5MM X 150MM / WITH FLANGE
414847

  • Elbow ulna prosthesis trial
No Description
Biomet Orthopedics, LLC
414846
In Commercial Distribution

  • 00880304369962 ()

  • 4MM X 150MM / WITH FLANGE
414846

  • Elbow ulna prosthesis trial
No Description
Biomet Orthopedics, LLC
414843
In Commercial Distribution

  • 00880304369955 ()

  • 6MM X 150MM / WITH FLANGE
414843

  • Elbow ulna prosthesis trial
No Description
Biomet Orthopedics, LLC
414842
In Commercial Distribution

  • 00880304369948 ()

  • 5MM X 150MM / WITH FLANGE
414842

  • Elbow ulna prosthesis trial
No Description
Biomet Orthopedics, LLC
414841
In Commercial Distribution

  • 00880304369931 ()

  • 4MM X 150MM / WITH FLANGE
414841

  • Elbow ulna prosthesis trial
No Description
Biomet Orthopedics, LLC
414832
In Commercial Distribution

  • 00880304369887 ()

  • 5MM X 100MM / WITH FLANGE
414832

  • Elbow ulna prosthesis trial
No Description
Biomet Orthopedics, LLC
32-347849
In Commercial Distribution

  • 00880304328891 ()

  • 1/16 DRILL WITH STOP
32-347849

  • Orthopaedic osteotome blade, reusable
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