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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Extended Tip Applicator EXTENDED TIP APPLICATOR, Single Use Applicator, 15CM
Integra Lifesciences Corporation
205115
In Commercial Distribution

  • 10381780000150 ()
  • 30381780000154 ()

  • Length: 15 Centimeter
205115

  • Open-surgery adhesive/sealant applicator, dual-channel
No Description
Alcon Laboratories, Inc.
2020
In Commercial Distribution

  • 00864461000401 ()
2020

  • Eyelid thermal pulsation system control unit
ASSEMBLY PKGD LIPIFLOW - US
TEARSCIENCE, INC.
LFTP-1000
In Commercial Distribution

  • 00859623006414 ()

  • Pressure: 6 Pound per Square Inch
210000

  • Eyelid thermal pulsation system control unit
PHENOL APPLICATOR
Grace Medical, Inc.
907
Not in Commercial Distribution

  • 00844505008129 ()


  • General-purpose absorbent tip applicator/swab, reusable
HDRE Applicator
ELEKTA LIMITED
1525345
In Commercial Distribution

  • 05060191071000 ()


  • Linear accelerator system
PLT Applicator
Kulzer GmbH
66019748
In Commercial Distribution

  • J014660197480 ()
66019748

  • Dental material cartridge-plunging applicator, single-component
Disc Applicator
Pixie Cup LLC
B0CGQ3YW9M
In Commercial Distribution

  • 00850016867728 ()


  • Vaginal applicator, reusable
Cup Applicator
Pixie Cup LLC
B0BCZMPVF9
In Commercial Distribution

  • 00850016867377 ()


  • Vaginal applicator, reusable
MACI Applicator
VERICEL CORPORATION
82032
In Commercial Distribution

  • 00850037506002 ()
N/A

  • Orthopaedic graft inserter, single-use
CoolCurve Applicator
Zeltiq Aesthetics, Inc.
BRZ-AP1-062-000
In Commercial Distribution

  • 00816417021008 ()
BRZ-AP1-062-000

  • Cryolipolysis body contouring system applicator
CooolSmooth Applicator
Zeltiq Aesthetics, Inc.
BRZ-AP1-091-000
In Commercial Distribution

  • 00816417020254 ()
BRZ-AP1-091-000

  • Cryolipolysis body contouring system applicator
Thigh Applicator
Zeltiq Aesthetics, Inc.
BRZ-AP2-360-000
In Commercial Distribution

  • 00816417021145 ()
BRZ-AP2-360-000

  • Cryolipolysis body contouring system applicator
CoolAdvantage Applicator
Zeltiq Aesthetics, Inc.
BRZ-AP2-160-000
In Commercial Distribution

  • 00816417020575 ()
BRZ-AP2-160-000

  • Cryolipolysis body contouring system applicator
CoolCurve+ Applicator
Zeltiq Aesthetics, Inc.
BRZ-AP1-064-000
In Commercial Distribution

  • 00816417020193 ()
BRZ-AP1-064-000

  • Cryolipolysis body contouring system applicator
CoolCore Applicator
Zeltiq Aesthetics, Inc.
BRZ-AP1-063-000
In Commercial Distribution

  • 00816417020179 ()
BRZ-AP1-063-000

  • Cryolipolysis body contouring system applicator
Applicator Adapter
Zeltiq Aesthetics, Inc.
BRZ-ADP-000-000
In Commercial Distribution

  • 00816417020124 ()
BRZ-ADP-000-000

  • Cryolipolysis body contouring system applicator
CoolMini Applicator
Zeltiq Aesthetics, Inc.
BRZ-AP2-020-000
In Commercial Distribution

  • 00816417020063 ()
BRZ-AP2-020-000

  • Cryolipolysis body contouring system applicator
Applicator Ø15mm
E.M.S. Electro Medical Systems S.A.
EL-158
In Commercial Distribution

  • 07613353000042 ()


  • Pneumatic orthopaedic extracorporeal shock wave therapy system
TACK APPLICATOR
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
62-302
Not in Commercial Distribution

  • H834623020 ()
  • 10381780038269 ()
62-302

  • Dental regeneration membrane fixation tack, non-bioabsorbable
Endoloop Applicator
STRYKER CORPORATION
0250080701
Not in Commercial Distribution

  • 07613327058666 ()

  • Outer Diameter: 5.0 Millimeter
0250-080-701

  • Endoscopic suturing unit, reusable
Adhesive applicator
MC10, INC.
BRCA05
Not in Commercial Distribution

  • B493BRCA05 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
ESOPHAGEAL APPLICATOR
Bionix Radiation Therapy, LLC
E-APP-1-VS
Not in Commercial Distribution

  • 00817740020997 ()

  • Length: 11 Centimeter
  • BALLOON OUTER DIAMETER
  • TREATMENT LENGTH OF BALLOONS
  • Outer Diameter: 20 Millimeter
E-APP-1-VS

  • Oesophagus brachytherapy system applicator, remote-afterloading
ESOPHAGEAL APPLICATOR
Bionix Radiation Therapy, LLC
E-APP-1
Not in Commercial Distribution

  • 00817740020980 ()

  • Length: 11 Centimeter
  • Outer Diameter: 20 Millimeter
  • BALLOON OUTER DIAMETER
  • TREATMENT LENGTH OF BALLOONS
E-APP-1

  • Oesophagus brachytherapy system applicator, remote-afterloading
ANORECTAL APPLICATOR
Bionix Radiation Therapy, LLC
AR-2-35x80
Not in Commercial Distribution

  • 00817740020973 ()

  • INNER BALLOON LENGTH
  • Length: 80 Millimeter
  • Outer Diameter: 35 Millimeter
  • INNER BALLOON DIAMETER
AR-2-35x80

  • Anorectal brachytherapy system applicator, remote-afterloading
ANORECTAL APPLICATOR
Bionix Radiation Therapy, LLC
AR-1-40x100
Not in Commercial Distribution

  • 00817740020966 ()

  • INNER BALLOON DIAMETER
  • INNER BALLOON LENGTH
  • Outer Diameter: 40 Millimeter
  • Length: 100 Millimeter
AR-1-40x100

  • Anorectal brachytherapy system applicator, remote-afterloading
Adhesive Applicator
Medidata Solutions, Inc.
BRCA05
In Commercial Distribution



  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
PIN - APPLICATOR
Helmut Zepf Medizintechnik GmbH
47.520.01
In Commercial Distribution

  • EZPF47520010 ()
47.520.01

  • Dental regeneration membrane fixation tack, non-bioabsorbable
Endoscopic Applicator
ETHICON, LLC
3123SPEA
In Commercial Distribution

  • 20705031237510 ()
  • 10705031237513 ()
3123SPEA

  • Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use
Lathbury Applicator,
Avalign Technologies, Inc.
VM21-6521
In Commercial Distribution

  • 00190776046026 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Farrell Applicator,
Avalign Technologies, Inc.
VM21-6516
In Commercial Distribution

  • 00190776046019 ()


  • General-purpose absorbent tip applicator/swab, reusable
Farrell Applicator,
Avalign Technologies, Inc.
VM21-6511
In Commercial Distribution

  • 00190776046002 ()


  • General-purpose absorbent tip applicator/swab, reusable
SCALPFIX APPLICATOR
Aesculap AG
FF012R
In Commercial Distribution

  • 04038653222841 ()
FF012R

  • Scalp clip applier, reusable
Head Applicator
ATLAS SPINE, INC.
2006-05-0000
In Commercial Distribution

  • M68120060500000 ()
2006-05-0000

  • Surgical implant/trial-implant/sizer holder, reusable
SculpSure Applicator
Cynosure, LLC
100-7026-100
In Commercial Distribution

  • 00841494100049 ()


  • Low-intensity laser fat liquefaction system
Cotton Applicator
Karl Storz GmbH & Co. KG
600800
In Commercial Distribution

  • 04048551179062 ()


  • Flexible endoscopic sponge/swab forceps
Laryngeal Applicator
Karl Storz GmbH & Co. KG
771000
In Commercial Distribution

  • 04048551198537 ()


  • Flexible endoscopic sponge/swab forceps
Laryngeal Applicator
Karl Storz GmbH & Co. KG
770800
In Commercial Distribution

  • 04048551198520 ()


  • Flexible endoscopic sponge/swab forceps
Loop Applicator
Karl Storz GmbH & Co. KG
757700
In Commercial Distribution

  • 04048551197752 ()


  • Nasal snare, reusable
Postnasal Applicator
Karl Storz GmbH & Co. KG
726000
In Commercial Distribution

  • 04048551194805 ()


  • Flexible endoscopic sponge/swab forceps
Lathbury Applicator,
Avalign Technologies, Inc.
VM21-6526
In Commercial Distribution

  • 00190776213398 ()


  • General-purpose absorbent tip applicator/swab, reusable
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