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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#9 Ring Pessary with Incontinence Knob with support.
MARINA MEDICAL INSTRUMENTS, INC.
BRK4.00S
In Commercial Distribution

  • 00840306836343 ()
BRK4.00S

  • Pelvic-organ-supporting pessary
#8 Ring Pessary with Incontinence Knob with supp
MARINA MEDICAL INSTRUMENTS, INC.
BRK.375S
In Commercial Distribution

  • 00840306836336 ()
BRK3.75S

  • Pelvic-organ-supporting pessary
Argintaw Pin Clamp with 2mm Pin with Suture
INNOMED, INC.
8315-00
In Commercial Distribution

  • 00840277116307 ()
8315-00

  • Surgical drill guide, reusable
SeroVac® Drain, With Needle, With Connection Tubing
AXIOM MEDICAL, INCORPORATED
214
In Commercial Distribution

  • M6652143 ()
  • M6652141 ()
  • M6652140 ()

  • 14 gauge
  • Length: 3.5 Inch


  • Closed-wound drain, non-bioabsorbable
SeroVac® Drain, With Needle, With Connection Tubing
AXIOM MEDICAL, INCORPORATED
212
In Commercial Distribution

  • M6652123 ()
  • M6652121 ()
  • M6652120 ()

  • Length: 3.5 Inch
  • 14 gauge


  • Closed-wound drain, non-bioabsorbable
DreamStation Go CPAP with Bluetooth, with Battery, USA
Respironics, Inc.
DreamStation Go CPAP w/Bluetooth, w/Battery, US
In Commercial Distribution

  • 00606959047266 ()
DSG400B11

  • Home CPAP unit
DreamStation WiFi Accessory, with Oximetry, with PRI, EU
Respironics, Inc.
DreamStation Wi-Fi Accessory with Oximetry, PRI, EU
Not in Commercial Distribution

  • 00606959047204 ()
100720W

  • Medical networking interface unit
DreamStation BiPAP ST30 with Humidifier, with Cell, DOM
Respironics, Inc.
00
In Commercial Distribution

  • 00606959045590 ()
DSX1030H11C

  • Portable electric ventilator
DreamStation BiPAP ST30 with Humidifier, with WiFi, DOM
Respironics, Inc.
00
In Commercial Distribution

  • 00606959045569 ()
DSX1030H11W

  • Portable electric ventilator
Bowel Grasper with ratchet Rotating, with flush Custom
Avalign Technologies, Inc.
LA8239-X
In Commercial Distribution

  • 00190776001025 ()

  • Width: 5 Millimeter
  • Length: 35 Centimeter


  • Rigid endoscopic tissue manipulation forceps, reusable
Bowel Grasper with ratchet Rotating, with flush Custom
Avalign Technologies, Inc.
LA8239X
In Commercial Distribution

  • 00190776001018 ()

  • Length: 35 Centimeter
  • Width: 5 Millimeter


  • Rigid endoscopic tissue manipulation forceps, reusable
Elvarex 1/Glove/With Finger, with Thumb/Caramel
BSN-Jobst GmbH
77325-00014-00
In Commercial Distribution

  • 04019702318784 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Glove/With Finger, with Thumb/Zipper
BSN-Jobst GmbH
77325-00004-00
In Commercial Distribution

  • 04019702316544 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Glove/With Finger, with Thumb/Black
BSN-Jobst GmbH
77325-00009-00
In Commercial Distribution

  • 04019702316490 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Glove/With Finger, with Thumb/Black
BSN-Jobst GmbH
77558-00025-00
In Commercial Distribution

  • 04019702288643 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Glove/With Finger, with Thumb/Caramel
BSN-Jobst GmbH
77558-00028-00
In Commercial Distribution

  • 04019702288612 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Glove/With Finger, with Thumb/Zipper
BSN-Jobst GmbH
77558-00018-00
In Commercial Distribution

  • 04019702287936 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Plus 1/Glove/With Finger, with Thumb
BSN-Jobst GmbH
79540-00000-00
In Commercial Distribution

  • 04019702523300 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Plus 2/Glove/With Finger, with Thumb
BSN-Jobst GmbH
79541-00000-00
In Commercial Distribution

  • 04019702512526 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Glove/With Finger, with Thumb/Honey
BSN-Jobst GmbH
77325-00032-00
In Commercial Distribution

  • 04019702540802 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 1/Glove/With Finger, with Thumb/Cranberry
BSN-Jobst GmbH
77325-00024-00
In Commercial Distribution

  • 04019702540727 ()

  • Pressure: 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex Forte 2/Glove/With Finger, with Thumb
BSN-Jobst GmbH
79581-00000-00
In Commercial Distribution

  • 04019702510621 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Glove/With Finger, with Thumb/Honey
BSN-Jobst GmbH
77558-00044-00
In Commercial Distribution

  • 04019702503852 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
Elvarex 2/Glove/With Finger, with Thumb/Cranberry
BSN-Jobst GmbH
77558-00036-00
In Commercial Distribution

  • 04019702502992 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
with Lok-Bar™ for use with Canon Orian
MEDTEC, INC.
MTM6508
In Commercial Distribution

  • 00841439112762 ()

  • Width: 609 Millimeter
  • Length: 2011 Millimeter
MTM6508

  • Indexed-immobilization patient positioning system
THERMOPLASTIC INSTRUMENT TRAY WITH MAT & LID WITH CLASPS
SONTEC INSTRUMENTS, INC.
18-3240
Not in Commercial Distribution

  • 00192896099159 ()

  • Height: 4.5 Inch
  • Width: 10 Inch
  • Length: 15 Inch
18-3240

  • Instrument tray, reusable
ELVAREX 1/GLOVE/WITH FINGER, WITH THUMB/NAVY
BSN-Jobst GmbH
77325-00040-00
In Commercial Distribution

  • 04059993105021 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 2/GLOVE/WITH FINGER, WITH THUMB/NAVY
BSN-Jobst GmbH
77558-00052-00
In Commercial Distribution

  • 04059993101856 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 1/GLOVE/WITH FINGER, WITH THUMB/CHERRY
BSN-Jobst GmbH
77325-00056-00
In Commercial Distribution

  • 04059993082131 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
ELVAREX 2/GLOVE/WITH FINGER, WITH THUMB/CHERRY
BSN-Jobst GmbH
77558-00068-00
In Commercial Distribution

  • 04059993063734 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
"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
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