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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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FILM XPRESS FV-57 NO. 2 ADULT F SPEED VALUE PAK - 00812045030306

F Speed, Size 2, 130 Double Film Packets.
Flow X Ray Corporation
18410E
In Commercial Distribution

  • 00812045030306 ()
  • 30812045030307 ()
  • 10812045030303 ()


  • Dental x-ray film, non-screen

FILM XPRESS FV-58 NO. 2 ADULT F SPEED VALUE PAK - 00812045030283

F Speed, Size 2, 150 Single Film Packets.
Flow X Ray Corporation
18310E
In Commercial Distribution

  • 00812045030283 ()
  • 10812045030280 ()
  • 30812045030284 ()


  • Dental x-ray film, non-screen

FILM DV-54 PEDO PAK D SPEED CHILD - 00812045030252

D Speed, Size 0, 100 Single Film Packets.
Flow X Ray Corporation
18235E
In Commercial Distribution

  • 00812045030252 ()
  • 10812045030259 ()
  • 30812045030253 ()


  • Dental x-ray film, non-screen

FILM XPRESS FV-54 ECONO PAK PEDO SIZE (0) - 00812045030221

F Speed, Size 0, 400 Single Film Packets.
Flow X Ray Corporation
18207
In Commercial Distribution

  • 00812045030221 ()


  • Dental x-ray film, non-screen

FILM DV-58 SILVER D ADULT VALUE PAK - 00812045030184

D Speed, Size 2, 150 Single Film Packets.
Flow X Ray Corporation
18200E
In Commercial Distribution

  • 00812045030184 ()
  • 10812045030181 ()
  • 30812045030185 ()


  • Dental x-ray film, non-screen

Green Team 612 - 6 x 12" Green Sensitive Panoramic Film - 00812045030160

Green Team 612 - 6 x 12" Green Sensitive Panoramic Film, Extraoral
Flow X Ray Corporation
18096-G
In Commercial Distribution

  • 00812045030160 ()
  • 30812045030161 ()


  • Dental x-ray film, screen

FILM 6 X 12 GREEN SENSITIVE PANORAMIC - 00812045030153

FILM, EXTRAORAL PANORAMIC, FILM 6 X 12 GREEN SENSITIVE PANORAMIC
Flow X Ray Corporation
18096G-E
In Commercial Distribution

  • 00812045030153 ()


  • Dental x-ray film, screen

FILM 6X12 TRUE BLUE SENSITIVE PANO - 00812045030146

FILM, EXTRAORAL PANORAMIC, FILM 6X12 TRUE BLUE SENSITIVE PANO
Flow X Ray Corporation
18096G-100
In Commercial Distribution

  • 00812045030146 ()


  • Dental x-ray film, screen

Green Team 512 - 5 x 12" Green Sensitive Panoramic Film - 00812045030139

Green Team 512 - 5 x 12" Green Sensitive Panoramic Film, Extraoral
Flow X Ray Corporation
18095-G
In Commercial Distribution

  • 00812045030139 ()
  • 30812045030130 ()


  • Dental x-ray film, screen

True Blue 612 - 6 x 12" Blue Sensitive Panoramic Film - 00812045030122

True Blue 612 - 6 x 12" Blue Sensitive Panoramic Film, Extraoral
Flow X Ray Corporation
18096
In Commercial Distribution

  • 00812045030122 ()
  • 30812045030123 ()


  • Dental x-ray film, screen

DX-58 ADULT PAPER PAK - 00812045030115

D Speed, Size 2, 150 Single Film Paper Packets.
Flow X Ray Corporation
18001
In Commercial Distribution

  • 00812045030115 ()
  • 10812045030112 ()
  • 20812045030119 ()


  • Dental x-ray film, non-screen

FILM 5X12 GREEN TEAM GREEN SENSITIVE PANORAMIC - 00812045030108

FILM, EXTRAORAL PANORAMIC, FILM 5X12 GREEN TEAM GREEN SENSITIVE PANORAMIC, 100pcs/box
Flow X Ray Corporation
18095G-100
In Commercial Distribution

  • 00812045030108 ()


  • Dental x-ray film, screen

FILM DX-42 NO. 3 BITE-CHEX PAPER BITEWING D SPEED - 00812045030061

D Speed, Size 3, 100 Single Film Paper Packets
Flow X Ray Corporation
18060-E
In Commercial Distribution

  • 00812045030061 ()


  • Dental x-ray film, non-screen

FILM INTRAORAL X-RAY - 00812045030023

D Speed, Size 2, 150 Single Film Paper Packets.
Flow X Ray Corporation
18001-E
In Commercial Distribution

  • 00812045030023 ()


  • Dental x-ray film, non-screen

RUSCH - 14026704711939

SNAPLIGHT SET:GREEN SPEC HAND+ MAC 2,3,4 +MILL 0
TELEFLEX INCORPORATED
IPN915513
In Commercial Distribution

  • 54026704711937 ()
  • 14026704711939 ()
  • 24026704711936 ()
4272/X

  • Rigid optical laryngopharyngoscope

RUSCH - 14026704711915

SNAPLIGHT SET:GREEN SPEC HANDLE + MILL 00,1,2,3
TELEFLEX INCORPORATED
IPN915511
In Commercial Distribution

  • 54026704711913 ()
  • 14026704711915 ()
  • 24026704711912 ()
4263/X

  • Rigid optical laryngopharyngoscope

RUSCH - 14026704711885

SNAPLIGHT SET: GREEN SPEC HANDLE + MAC 1,2,3,4
TELEFLEX INCORPORATED
IPN915508
In Commercial Distribution

  • 54026704711883 ()
  • 14026704711885 ()
  • 24026704711882 ()
4261/X

  • Rigid optical laryngopharyngoscope

RUSCH - 14026704711946

SNAPLIGHT SET:GREEN SPEC HAND + MAC 2,3,4+MILL 1
TELEFLEX INCORPORATED
IPN915514
In Commercial Distribution

  • 54026704711944 ()
  • 14026704711946 ()
  • 24026704711943 ()
4273/X

  • Rigid optical laryngopharyngoscope

RUSCH - 14026704711908

SNAPLIGHT SET:GREEN SPEC HANDLE + MAC 2,3,4
TELEFLEX INCORPORATED
IPN915510
In Commercial Distribution

  • 54026704711906 ()
  • 14026704711908 ()
  • 24026704711905 ()
4262/X

  • Rigid optical laryngopharyngoscope

RUSCH - 14026704614452

SNAPLIGHT SET:GREEN SPEC HAND + MAC 2,3,4+MILL 1
TELEFLEX INCORPORATED
IPN048557
In Commercial Distribution

  • 44026704614453 ()
  • 14026704614452 ()
  • 34026704612063 ()
4273/X

  • Rigid optical laryngopharyngoscope

RUSCH - 14026704614445

SNAPLIGHT SET:GREEN SPEC HAND+ MAC 2,3,4 +MILL 0
TELEFLEX INCORPORATED
IPN048556
In Commercial Distribution

  • 44026704614446 ()
  • 14026704614445 ()
  • 34026704612063 ()
4272/X

  • Rigid optical laryngopharyngoscope

RUSCH - 14026704614421

SNAPLIGHT SET:GREEN SPEC HANDLE + MILL 00,1,2,3
TELEFLEX INCORPORATED
IPN048553
In Commercial Distribution

  • 44026704614422 ()
  • 14026704614421 ()
  • 34026704612063 ()
4263/X

  • Rigid optical laryngopharyngoscope

RUSCH - 14026704614414

SNAPLIGHT SET:GREEN SPEC HANDLE + MAC 2,3,4
TELEFLEX INCORPORATED
IPN048552
In Commercial Distribution

  • 44026704614415 ()
  • 14026704614414 ()
  • 34026704612063 ()
4262/X

  • Rigid optical laryngopharyngoscope

RUSCH - 14026704614407

SNAPLIGHT SET: GREEN SPEC HANDLE + MAC 1,2,3,4
TELEFLEX INCORPORATED
IPN048551
In Commercial Distribution

  • 44026704614408 ()
  • 14026704614407 ()
  • 34026704612063 ()
4261/X

  • Rigid optical laryngopharyngoscope

Delasco SaftEvac Filter - 00609960001296

FILTER PACK, FILTER, 6 ft HOSE, REDUCER & NARROW TUBING. Medical Device.
DERMATOLOGIC LAB AND SUPPLY, INC.
EV/X
In Commercial Distribution

  • 00609960001296 ()
EV/X

  • Surgical plume evacuation system filter

TIP for LITETOUCH - 07290016784060

Package of 5 single-use tips for the LITETOUCH system
LIGHT INSTRUMENTS LTD
ENDO
In Commercial Distribution

  • 07290016784060 ()
  • 37290016784061 ()
LI-FG4001(X)

  • Dental solid-state laser system

D-STORM - 07290016784046

Base (station)
LIGHT INSTRUMENTS LTD
1
In Commercial Distribution

  • 07290016784046 ()
LI-FGD002(X)

  • Dental solid-state laser system

D-STORM - 07290016784039

Diode (portable)
LIGHT INSTRUMENTS LTD
1
In Commercial Distribution

  • 07290016784039 ()
LI-FGD001(X)

  • Dental solid-state laser system

EmbraceTM Electrodes Array (L) - 07290016406030

Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit.
O.B - TOOLS LTD
FG0003(X)
Not in Commercial Distribution

  • 07290016406030 ()
  • 17290016406037 ()
  • 27290016406034 ()

  • Width: 280 Millimeter
  • Length: 320 Millimeter
FG0003(X)

  • Cardiotocography telemetric monitoring system

TrueLabor Monitor Adapter - 07290016406023

The TrueLabor's Monitor Adapter for the hospital maternal/fetal monitoring system. The corresponding Maternal Unit transmits the uterine activity/fetal heart rate information via Bluetooth to the MONITOR ADAPTER which transfers it to the hospital monitor or directly to the hospital IT system.
O.B - TOOLS LTD
FG0002(X)
In Commercial Distribution

  • 07290016406023 ()

  • Depth: 30 Millimeter
  • Width: 200 Millimeter
  • Height: 120 Millimeter
  • Weight: 400 Gram
FG0002(X)

  • Cardiotocography telemetric monitoring system

TrueLabor Maternal Unit - 07290016406016

TrueLabor's Maternal Unit is connected via a proprietary connector to the Embrace electrode array. The MU acquires EMG signals and provides Fetal Heart Rate and Uterine Activity are transmitted via Bluetooth. The unit contains a Li-Ion rechargeable battery.
O.B - TOOLS LTD
FG0001(X)
In Commercial Distribution

  • 07290016406016 ()

  • Width: 90 Millimeter
  • Height: 125 Millimeter
  • Depth: 29 Millimeter
  • Weight: 240 Gram
FG0001(X)

  • Cardiotocography telemetric monitoring system

Bausch + Lomb - 00757770404353

SCS COR'L SEC CAST LT SUB MINI
Bausch & Lomb Incorporated
E3305 X
In Commercial Distribution

  • 00757770404353 ()
E3305 X

  • Corneal scissors, reusable

Bausch + Lomb - 00757770420605

SCS COR'L CAST RT SUB MIN
Bausch & Lomb Incorporated
E3304 X
In Commercial Distribution

  • 00757770420605 ()
E3304 X

  • Corneal scissors, reusable

PlasmaFlow X - 00850998008478

The PlasmaFlow X is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: Aid in the prevention of DVT Enhance blood circulation Diminish post-operative pain and swelling Reduce wound healing time Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
Manamed, Inc.
XPF0001
In Commercial Distribution

  • 00850998008478 ()
XPF0001

  • Intermittent venous compression system

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

PALS X - 00851913006418

PALS X 2" x 4" rectangle
AXELGAARD MANUFACTURING CO., LTD.
PX2040
In Commercial Distribution

  • 00851913006418 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

PALS X - 00851913006401

PALS X 2" x 2" square
AXELGAARD MANUFACTURING CO., LTD.
PX2020
In Commercial Distribution

  • 00851913006401 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

Modus X - 00670082000566

Robotic Exoscope
Synaptive Medical Inc
SYN-0976
In Commercial Distribution

  • 00670082000566 ()


  • General-purpose surgical microscope

SureFit X - 00852598007219

Constriction Ring
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Constriction Ring
In Commercial Distribution

  • 00852598007219 ()


  • Penile vacuum device

Modus X - 00670082000573

Robotic Exoscope
Synaptive Medical Inc
SYN-0974
In Commercial Distribution

  • 00670082000573 ()


  • General-purpose surgical microscope

UltraStim X - 00856817005871

No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2040-4
Not in Commercial Distribution

  • 00856817005871 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

UltraStim X - 00856817005833

No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2040
In Commercial Distribution

  • 00856817005833 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

UltraStim X - 00856817005826

No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2020
In Commercial Distribution

  • 00856817005826 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

UltraStim X - 00856817005819

No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2000
In Commercial Distribution

  • 00856817005819 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable

X PRO - 06430035872848

No Description
PaloDEx Group Oy
IOS-1
In Commercial Distribution

  • 06430035872848 ()


  • Dental milling system, CAD/CAM, chairside

X FIX - 00880304491892

No Description
Biomet Orthopedics, LLC
03125
In Commercial Distribution

  • 00880304491892 ()
03125

  • Surgical torque wrench, reusable

X FIX - 00880304490819

No Description
Biomet Orthopedics, LLC
03115
In Commercial Distribution

  • 00880304490819 ()
03115

  • Surgical torque wrench, reusable

X FIX - 00880304487253

No Description
Biomet Orthopedics, LLC
03110
In Commercial Distribution

  • 00880304487253 ()
03110

  • Surgical torque wrench, reusable

X FIX - 00880304498129

No Description
Biomet Orthopedics, LLC
05005
In Commercial Distribution

  • 00880304498129 ()
05005

  • Surgical torque wrench, reusable

X FIX - 00880304497962

No Description
Biomet Orthopedics, LLC
03122
In Commercial Distribution

  • 00880304497962 ()
03122

  • Surgical torque wrench, reusable
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