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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 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

FibriJet - 00815634021730

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

  • 10815634021737 ()
  • 00815634021730 ()


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

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

Arthrex® - 00888867018556

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

  • 00888867018556 ()
AR-1529

  • Orthopaedic graft tensioner, reusable

Surgical Direct - B382SD12499A0

Cholangiogram Forceps with Ratchet
Surgical Direct, Inc.
SD12499A
In Commercial Distribution

  • B382SD12499A0 ()
SD12499A

  • Flexible endoscopic tissue manipulation forceps, single-use

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

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

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

Arthrex® - 00888867231313

FiberTak with #2 TigerTail
ARTHREX, INC.
AR-3603
In Commercial Distribution

  • 00888867231313 ()
  • M150AR36031 ()
  • 10888867231310 ()
AR-3603

  • Tendon/ligament bone anchor, non-bioabsorbable

SafeGuide® - 00816734020982

Guidewire with Spring Tip
DIVERSATEK HEALTHCARE, INC.
1214-02S
In Commercial Distribution

  • 00816734020982 ()

  • Length: 210 Centimeter
1214-02S

  • Over-guidewire oesophageal dilator

SafeGuide® - 00816734020975

Guidewire with Spring Tip
DIVERSATEK HEALTHCARE, INC.
1214-02
In Commercial Distribution

  • 10816734020972 ()
  • 00816734020975 ()

  • Length: 210 Centimeter
1214-02

  • Over-guidewire oesophageal dilator

PROBASICS - 00815067071913

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

  • 00815067071913 ()
  • 30815067071914 ()


  • Seat toilet pan

Sun Medical Inc - B226844002

Aspirator Tubing with adaptor
SUN MEDICAL INC
84400
In Commercial Distribution

  • B226844002 ()
  • B844002 ()
84400

  • Suction cannula, single-use
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