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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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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 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® 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

Parcus Instrumentation - 00816342021258

3.2mm Awl with Handle
PARCUS MEDICAL LLC
10365
In Commercial Distribution

  • 00816342021258 ()

  • Outer Diameter: 3.4 Millimeter


  • Bone awl, reusable

Complete MultiBlast Medium® with SSS - 00893727002279

Complete MultiBlast With SSS
FUJIFILM IRVINE SCIENTIFIC, INC.
90141-2X20mL
Not in Commercial Distribution

  • 00893727002279 ()
  • 18937270022793 ()

  • Total Volume: 20 Milliliter
90141

  • IVF medium

MultiBlast Medium® - 00893727002255

MultiBlast Medium with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90139-60mL
Not in Commercial Distribution

  • 00893727002255 ()

  • Total Volume: 60 Milliliter
90139

  • IVF medium

Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin - 00893727002217

Freezing Medium With Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90128-20X5mL
In Commercial Distribution

  • 00893727002217 ()
  • 10893727002214 ()

  • Total Volume: 5 Milliliter
90128

  • IVF medium

Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin - 00893727002200

Freezing Medium With Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90128-100mL
In Commercial Distribution

  • 00893727002200 ()

  • Total Volume: 100 Milliliter
90128

  • IVF medium

PROBASICS - 00815067071913

SHOWER CHAIR WITH BACK
COMPASS HEALTH BRANDS CORP.
BSCWB
In Commercial Distribution

  • 00815067071913 ()
  • 30815067071914 ()


  • Seat toilet pan

BOSS Instruments - 00888515034365

Endoscope Holder with Arm
BOSS INSTRUMENTS, LTD., INC.
18-4900
In Commercial Distribution

  • 00888515034365 ()
18-4900

  • Surgical retractor/retraction system blade, reusable

Earhook - 07630016851216

Standard with grip (10)
Advanced Bionics AG
CI-6147-013
Not in Commercial Distribution

  • 07630016851216 ()
  • 07630016855856 ()


  • Cochlear implant/auditory brainstem implant sound processor

Earhook - 07630016851209

Small with grip (10)
Advanced Bionics AG
CI-6147-012
Not in Commercial Distribution

  • 07630016851209 ()
  • 07630016855863 ()


  • Cochlear implant/auditory brainstem implant sound processor

MicroFrance® - 10381780099451

Monopolar Forceps with Teeth
INTEGRA MICROFRANCE
CP390-8
In Commercial Distribution

  • 10381780099451 ()

  • Length: 190 Millimeter
CP390-8

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Arthrex® - 00888867001862

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

  • 00888867001862 ()
ABS-1002

  • Bone access cannula

Surgical Direct - B382SD40909B0

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

  • B382SD40909B0 ()
SD40909B

  • Rigid optical cystoscope

FibriJet - 00815634021730

Blending Connector with Mixer
Micromedics, Inc.
SA-3678
In Commercial Distribution

  • 10815634021737 ()
  • 00815634021730 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

Arthrex® - 00888867001817

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

  • 00888867001817 ()
ABS-1001

  • Bone access cannula

Arthrex® - 00888867020825

DRILL GUIDE WITH TEETH
ARTHREX, INC.
AR-1678-01
In Commercial Distribution

  • 00888867020825 ()
AR-1678-01

  • Surgical drill guide, reusable

Arthrex® - 00888867018556

SUTURE TENSIONER WITH TENSIOMETER
ARTHREX, INC.
AR-1529
In Commercial Distribution

  • 00888867018556 ()
AR-1529

  • Orthopaedic graft tensioner, reusable

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® 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 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

Arthrex® - 00888867010086

SCREWDRIVER WITH AO CONNECTION
ARTHREX, INC.
AR-13223
In Commercial Distribution

  • 00888867010086 ()
AR-13223

  • Surgical screwdriver, reusable

Arthrex® - 00888867308459

ACL TightRope with FiberTag
ARTHREX, INC.
AR-1588RTT
In Commercial Distribution

  • 00888867308459 ()
AR-1588RTT

  • Tendon/ligament bone anchor, non-bioabsorbable

Arthrex® - 00888867293496

FastPass SCORPION-mf with FlushPort
ARTHREX, INC.
AR-13997MFF
In Commercial Distribution

  • 00888867293496 ()
AR-13997MFF

  • Suturing unit, reusable

Arthrex® - 00888867293380

Curved Scorpion with FlushPort
ARTHREX, INC.
AR-13998CF
In Commercial Distribution

  • 00888867293380 ()
AR-13998CF

  • Suturing unit, reusable

Arthrex® - 00888867293328

NanoRetriever, 130mm with FlushPort
ARTHREX, INC.
AR-10914F
In Commercial Distribution

  • 10888867293325 ()
  • 00888867293328 ()
AR-10914F

  • Suturing unit, reusable

StimRouter Clinician's Kit - 00815962020023

Clinician’s Programmer with Software
BIONESS INC.
ST2-4000
In Commercial Distribution

  • 00815962020023 ()


  • Analgesic PENS system probe, single-use

Arthrex® - 00888867040397

EXPANULA WITH NO-SQUIRT CAP
ARTHREX, INC.
AR-6569
In Commercial Distribution

  • 10888867040394 ()
  • 00888867040397 ()
AR-6569

  • Arthroscopic access cannula seal, single-use

Terumo Cardiovascular Systems - 00817278010774

Multi-Perfusion Adapter with Vent
Med Michigan Holdings, LLC
824368
In Commercial Distribution

  • 10817278010771 ()
  • 00817278010774 ()
824368

  • Cardioplegia solution administration adaptor

Spine Instruments - 07630971237247

Flat bender with pins
Medacta International SA
03.51.10.0416
In Commercial Distribution

  • 07630971237247 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867381636

NanoRetriever, 130mm with FlushPort
ARTHREX, INC.
AR-10914F-1
In Commercial Distribution

  • 00888867381636 ()
AR-10914F-1

  • Suturing unit, reusable

Arthrex® - 00888867381575

NanoRetriever, 70mm with FlushPort
ARTHREX, INC.
AR-10904F-1
In Commercial Distribution

  • 00888867381575 ()
AR-10904F-1

  • Suturing unit, reusable

Surgical Direct - B382SDM172040

Handle, with Mini Coupling
Surgical Direct, Inc.
SDM17204
In Commercial Distribution

  • B382SDM172040 ()
SDM17204

  • Surgical screwdriver, reusable

Arthrex® - 00888867293465

FastPass Scorpion with FlushPort
ARTHREX, INC.
AR-13997SFF
In Commercial Distribution

  • 00888867293465 ()
AR-13997SFF

  • Suturing unit, reusable

Arthrex® - 00888867293243

NanoRetriever, 70mm with FlushPort
ARTHREX, INC.
AR-10904F
In Commercial Distribution

  • 10888867293240 ()
  • 00888867293243 ()
AR-10904F

  • Suturing unit, reusable

Hip Instruments - 07630040735131

Large Blade with pins
Medacta International SA
01.15.10.0089
In Commercial Distribution

  • 07630040735131 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Hip Instruments - 07630040735124

Small Blade with pins
Medacta International SA
01.15.10.0088
In Commercial Distribution

  • 07630040735124 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Arthrex® - 00888867120976

FIBERTAPE, BLUE WITH NEEDLES
ARTHREX, INC.
AR-7237-7N
Not in Commercial Distribution

  • 00888867120976 ()
AR-7237-7N

  • Polyolefin/fluoropolymer suture, multifilament

Arthrex® - 00888867118140

DUALWAVE WITH REMOTE SET
ARTHREX, INC.
AR-6480-SR
Not in Commercial Distribution

  • 00888867118140 ()
  • M150AR6480SR0 ()
AR-6480-SR

  • Arthroscopic surgical procedure kit, non-medicated, single-use
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