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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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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
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
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
No Description
WESTMED, INC.
9443
In Commercial Distribution

  • 10709078004824 ()
  • 00709078004827 ()


  • Oxygen administration tubing
No Description
WESTMED, INC.
9442
In Commercial Distribution

  • 10709078004817 ()
  • 00709078004810 ()


  • Oxygen administration tubing
No Description
SAKAMURA KENKYUSHO, K.K.
8010141
In Commercial Distribution

  • 04955114013155 ()


  • Ear microsystem seed/pellet
300 units in single package
SAKAMURA KENKYUSHO, K.K.
8010140
In Commercial Distribution

  • 04955114013148 ()


  • Ear microsystem seed/pellet
300 units in single package
SAKAMURA KENKYUSHO, K.K.
8010011
In Commercial Distribution

  • 04955114013124 ()


  • Ear microsystem seed/pellet
300 units in single package
SAKAMURA KENKYUSHO, K.K.
8010010
In Commercial Distribution

  • 04955114013117 ()


  • Ear microsystem seed/pellet
No Description
Promepla
ONGR2001ST12
In Commercial Distribution

  • 03700512920991 ()
  • 03700512910992 ()
  • 03700512900993 ()
ONGR2001ST12

  • Surgical irrigation/aspiration tubing set
Markings - 17 x 100 mm, STERILE-R
Dynarex Corporation
42306
In Commercial Distribution

  • 00810180841146 ()
  • 00840117337213 ()
  • 00840117335042 ()


  • Culture tube
No Description
Varian Medical Systems Deutschland GmbH
GM11007010
In Commercial Distribution

  • 00816389023949 ()
GM11007010

  • General-purpose brachytherapy system applicator, remote-afterloading
No Description
Varian Medical Systems Deutschland GmbH
GM11007000
In Commercial Distribution

  • 00816389023932 ()
GM11007000

  • General-purpose brachytherapy system applicator, remote-afterloading
No Description
GLOBAL SURGICAL CORPORATION
M 528X
In Commercial Distribution

  • 00810040251351 ()


  • General-purpose surgical microscope
OxyMask CO2 with oxygen Tubing 14ft with Sampling Line Male 15ft
Southmedic Incorporated
OM-2125-14SLM
In Commercial Distribution

  • 10620974001659 ()
  • 00620974001652 ()

  • OxyMask CO2 with oxygen Tubing 14ft with Sampling Line Male 15ft
OM-2125-14SLM

  • Breathing circuit gas-sampling/monitoring set
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
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/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
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
Self-cure resin based impression material for the fabrication of temporary crowns and bridges
ADVANTAGE DENTAL PRODUCTS INC
102
In Commercial Distribution

  • 10859787002021 ()
  • 00859787002024 ()

  • Total Volume: 50 Milliliter


  • Temporary dental crown/bridge resin
Self-cure resin based impression material for the fabrication of temporary crowns and bridges
ADVANTAGE DENTAL PRODUCTS INC
101
In Commercial Distribution

  • 10859787002014 ()
  • 00859787002017 ()

  • Total Volume: 50 Milliliter


  • Temporary dental crown/bridge resin
CPR CONNECTOR,REPLACEMENT,SERENE,PUMP
MEDLINE INDUSTRIES, INC.
MDT24SERCPRC
In Commercial Distribution

  • 10193489025217 ()
MDT24SERCPRC

  • Alternating-pressure bed mattress system
Medisorb™ Loose Fill Twinpack 4.5 kg (9.9 lb.), Disposable, Carbon Dioxide Absorbent
AirLife Finland Oy
8570043
In Commercial Distribution

  • 20889483590529 ()
  • 10889483590522 ()
8570043

  • Carbon dioxide absorbent
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