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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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Nuwave - 00812970012019

NUWAVE with Small Bag
EXCELERON MEDICAL, INC.
NW-002
In Commercial Distribution

  • 00812970012019 ()
NW-002

  • Home CPAP/BPAP washer-disinfector (ozone)

Kobold® Vaginal Cylinder Applicator Set (E) - 00815568020991

Labelled with CE mark
KOBOLD, LLC
715-000
In Commercial Distribution

  • 00815568020991 ()


  • Vaginal brachytherapy system applicator, remote-afterloading

Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E) - 00815568020984

Labelled with CE mark
KOBOLD, LLC
708-002
In Commercial Distribution

  • 00815568020984 ()

  • Cylinder-shaped ovoids


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E) - 00815568020977

Labelled with CE mark
KOBOLD, LLC
708-001
In Commercial Distribution

  • 00815568020977 ()

  • Barrel-shaped ovoids


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Kobold® Tandem and 30 Deg Ring Applicator Set (E) - 00815568020960

Labelled with CE mark
KOBOLD, LLC
707-004
In Commercial Distribution

  • 00815568020960 ()

  • Angle: 30 degree


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Kobold® Tandem and 45 Deg Ring Applicator Set (E) - 00815568020953

Labelled with CE mark
KOBOLD, LLC
707-003
In Commercial Distribution

  • 00815568020953 ()

  • Angle: 45 degree


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Kobold® Tandem and 60 Deg Ring Applicator Set (E) - 00815568020946

Labelled with CE mark
KOBOLD, LLC
707-002
In Commercial Distribution

  • 00815568020946 ()

  • Angle: 60 degree


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Kobold® Tandem and 30/45/60 Deg Ring Applicator Set (E) - 00815568020939

Labelled with CE mark
KOBOLD, LLC
707-001
In Commercial Distribution

  • 00815568020939 ()

  • Angle: 30 degree
  • Angle: 45 degree
  • Angle: 60 degree


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Kobold® Henschke-model Tandem and Ovoid Applicator Set (E) - 00815568020922

Labelled with CE mark
KOBOLD, LLC
704-000
In Commercial Distribution

  • 00815568020922 ()


  • Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Surgical Direct - B382SD40909B0

Cysto-Urethroscope Sheath with Obturator
Surgical Direct, Inc.
SD40909B
In Commercial Distribution

  • B382SD40909B0 ()
SD40909B

  • Rigid optical cystoscope

Arthrex® - 00888867001862

NEEDLE, STRAIGHT WITH OBTURATOR
ARTHREX, INC.
ABS-1002
In Commercial Distribution

  • 00888867001862 ()
ABS-1002

  • Bone access cannula

Arthrex® - 00888867001817

NEEDLE, TUOHY WITH OBTURATOR
ARTHREX, INC.
ABS-1001
In Commercial Distribution

  • 00888867001817 ()
ABS-1001

  • Bone access cannula

PIEZON - 07613353095482

Instrument SB with CombiTorque
E.M.S. Electro Medical Systems S.A.
a
In Commercial Distribution

  • 07613353095482 ()
DS-057D

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Heated Eye Pad Pro - B172PRO0

Ophthalmic warmer with timer
DIGITAL HEAT CORPORATION
Heated Eye Pad Pro
In Commercial Distribution

  • B172PRO0 ()


  • Eye heat therapy pack, reusable

n/a - 04048844519476

drill with depth marking
implantcast GmbH
02320025
In Commercial Distribution

  • 04048844519476 ()

  • Ø 3,2/25mm


  • Fluted surgical drill bit, reusable

n/a - 04048844519469

drill with depth marking
implantcast GmbH
02320020
In Commercial Distribution

  • 04048844519469 ()

  • Ø 3,2/20mm


  • Fluted surgical drill bit, reusable

n/a - 04048844519452

drill with depth marking
implantcast GmbH
02320015
In Commercial Distribution

  • 04048844519452 ()

  • Ø 3,2/15mm


  • Fluted surgical drill bit, reusable

PMI Probasics® - 00841447104285

Tens Unit with accessories
COMPASS HEALTH BRANDS CORP.
2004
Not in Commercial Distribution

  • 00841447104285 ()
2004

  • Analgesic transcutaneous electrical nerve stimulation system

n.a. - 04048551364970

Palpation Probe with cm-marking
Karl Storz GmbH & Co. KG
26167TNS
In Commercial Distribution

  • 04048551364970 ()
26167TNS

  • Endoscopic surgical probe

n.a. - 04048551364963

Palpation Probe with cm-markings
Karl Storz GmbH & Co. KG
26167TNL
In Commercial Distribution

  • 04048551364963 ()
26167TNL

  • Endoscopic surgical probe

n.a. - 04048551359563

Trocar with pyramidal tip
Karl Storz GmbH & Co. KG
11603ZS
In Commercial Distribution

  • 04048551359563 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551157671

Tray, with lid, 670x80x52mm
Karl Storz GmbH & Co. KG
39501C
In Commercial Distribution

  • 04048551157671 ()


  • Device sterilization/disinfection container, reusable

CLICKLINE - 04048551143018

Grasping Forceps, with scissors
Karl Storz GmbH & Co. KG
33410FS
In Commercial Distribution

  • 04048551143018 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

CLICKLINE - 04048551134269

Grasping Forceps, with scissors
Karl Storz GmbH & Co. KG
33310FS
In Commercial Distribution

  • 04048551134269 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

n.a. - 04048551124871

Handle with Outer Tube
Karl Storz GmbH & Co. KG
31535
In Commercial Distribution

  • 04048551124871 ()


  • Endoscope sheath, reusable

n.a. - 04048551124260

Handle with Two-Way Stopcock
Karl Storz GmbH & Co. KG
30805
In Commercial Distribution

  • 04048551124260 ()


  • Surgical instrument handle, non-torque-limiting

n.a. - 04048551124253

Handle with Trumpet Valve
Karl Storz GmbH & Co. KG
30804
In Commercial Distribution

  • 04048551124253 ()


  • Surgical instrument handle, non-torque-limiting

n.a. - 04048551123461

Handle with Outer Tube
Karl Storz GmbH & Co. KG
30535
In Commercial Distribution

  • 04048551123461 ()


  • Endoscope sheath, reusable

n.a. - 04048551123454

Handle with Outer Tube
Karl Storz GmbH & Co. KG
30529
In Commercial Distribution

  • 04048551123454 ()


  • Endoscope sheath, reusable

CLICKLINE - 04048551122976

Outer Tube with Insert
Karl Storz GmbH & Co. KG
30340VRS
In Commercial Distribution

  • 04048551122976 ()


  • Endoscope sheath, reusable

CLICKLINE - 04048551122969

Outer Tube with Insert
Karl Storz GmbH & Co. KG
30340VR
In Commercial Distribution

  • 04048551122969 ()


  • Endoscope sheath, reusable

CLICKLINE - 04048551121641

Outer Tube with Insert
Karl Storz GmbH & Co. KG
30240AS
In Commercial Distribution

  • 04048551121641 ()


  • Endoscope sheath, reusable

n.a. - 04048551115084

Operation Sheath with Handle
Karl Storz GmbH & Co. KG
28730H
In Commercial Distribution

  • 04048551115084 ()


  • Endoscope sheath, reusable

n.a. - 04048551265413

Optic-Lock plug with LUER-Lock
Karl Storz GmbH & Co. KG
26040BX
In Commercial Distribution

  • 04048551265413 ()


  • Endoscope assembly adaptor

CLICKLINE - 04048551265147

Metal Handle, with ratchet
Karl Storz GmbH & Co. KG
33141P
In Commercial Distribution

  • 04048551265147 ()


  • Surgical instrument handle, non-torque-limiting

n.a. - 04048551254776

Trocar, with pyramidal tip
Karl Storz GmbH & Co. KG
30114C
In Commercial Distribution

  • 04048551254776 ()


  • Laparoscopic trocar blade, reusable

CLICKLINE - 04048551125823

Grasping Forceps, with scissors
Karl Storz GmbH & Co. KG
33210FS
In Commercial Distribution

  • 04048551125823 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

CLICKLINE - 04048551125441

Metal Handle, with ratchet
Karl Storz GmbH & Co. KG
33141
In Commercial Distribution

  • 04048551125441 ()


  • Surgical instrument handle, non-torque-limiting

CLICKLINE - 04048551125397

Metal Handle, with ratchet
Karl Storz GmbH & Co. KG
33139
In Commercial Distribution

  • 04048551125397 ()


  • Surgical instrument handle, non-torque-limiting

CLICKLINE - 04048551125335

Metal Y-Handle, with ratchet
Karl Storz GmbH & Co. KG
33137
In Commercial Distribution

  • 04048551125335 ()


  • Surgical instrument handle, non-torque-limiting
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