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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FITTING KIT,M&RIE,SUREFIT 3
Gn Hearing A/S
21502900
In Commercial Distribution

  • 05708296210299 ()


  • Earmould, preformed
FITTING KIT,TMRIE M&RIE,SF3C
Gn Hearing A/S
22466000
In Commercial Distribution

  • 05708296265848 ()


  • Earmould, preformed
FITTING KIT,M&RIE,SF3B
Gn Hearing A/S
22125800
In Commercial Distribution

  • 05708296237807 ()


  • Earmould, preformed
FITTING KIT,REC,SF3B
Gn Hearing A/S
21997400
In Commercial Distribution

  • 05708296226351 ()


  • Earmould, preformed
KIT,UPKEEP ESSENTIALS
Gn Hearing A/S
23327300
In Commercial Distribution

  • 05708296355389 ()


  • Earmould, preformed
FITTING KIT,M&RIE AND STD,COMB
Gn Hearing A/S
22980000
In Commercial Distribution

  • 05708296319220 ()


  • Earmould, preformed
FITTING KIT,THIN TUBE,SF2C
Gn Hearing A/S
22955700
In Commercial Distribution

  • 05708296315055 ()


  • Earmould, preformed
CLOSED-LARGE/991016-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991016-SWH
In Commercial Distribution

  • 00850016231345 ()


  • Earmould, preformed
CLOSED-MEDIUM/991015-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991015-SWH
In Commercial Distribution

  • 00850016231338 ()


  • Earmould, preformed
CLOSED-SMALL/991014-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991014-SWH
In Commercial Distribution

  • 00850016231321 ()


  • Earmould, preformed
TULIP-ONE SIZE (12MM)/991013-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991013-SWH
In Commercial Distribution

  • 00850016231314 ()


  • Earmould, preformed
OPEN-LARGE/991012-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991012-SWH
In Commercial Distribution

  • 00850016231307 ()


  • Earmould, preformed
OPEN-MEDIUM/991011-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991011-SWH
In Commercial Distribution

  • 00850016231291 ()


  • Earmould, preformed
OPEN-SMALL/991010-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Soundwave Hearing, LLC
991010-SWH
In Commercial Distribution

  • 00850016231284 ()


  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z544994
In Commercial Distribution

  • 09321502038515 ()
  • 09321502042994 ()

  • 6mm diameter dome
  • Outer Diameter: 6 Millimeter
Z544994

  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z544995
In Commercial Distribution

  • 09321502038508 ()
  • 09321502043007 ()

  • 8mm diameter dome
  • Outer Diameter: 8 Millimeter
Z544995

  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z544996
In Commercial Distribution

  • 09321502038492 ()
  • 09321502043014 ()

  • Outer Diameter: 10 Millimeter
  • 10mm diameter dome
Z544996

  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z544997
In Commercial Distribution

  • 09321502038485 ()
  • 09321502043021 ()

  • Outer Diameter: 6 Millimeter
  • 6mm diameter dome
Z544997

  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z544998
In Commercial Distribution

  • 09321502038478 ()
  • 09321502043038 ()

  • 8mm diameter dome
  • Outer Diameter: 8 Millimeter
Z544998

  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z544999
In Commercial Distribution

  • 09321502038461 ()
  • 09321502043052 ()

  • Outer Diameter: 6 Millimeter
  • 6mm diameter dome
Z544999

  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z545000
In Commercial Distribution

  • 09321502038454 ()
  • 09321502043076 ()

  • 10mm diameter dome
  • Outer Diameter: 10 Millimeter
Z545000

  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z545001
In Commercial Distribution

  • 09321502038447 ()
  • 09321502043045 ()

  • 10mm diameter dome
  • Outer Diameter: 10 Millimeter
Z545001

  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z545002
In Commercial Distribution

  • 09321502038430 ()
  • 09321502043083 ()

  • 6mm diameter dome
  • Outer Diameter: 6 Millimeter
Z545002

  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z545003
In Commercial Distribution

  • 09321502038423 ()
  • 09321502043069 ()

  • Outer Diameter: 8 Millimeter
  • 8mm diameter dome
Z544003

  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z545004
In Commercial Distribution

  • 09321502038416 ()
  • 09321502043106 ()

  • Outer Diameter: 10 Millimeter
  • 10mm diameter dome
Z545004

  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z545005
In Commercial Distribution

  • 09321502038409 ()
  • 09321502043090 ()

  • Outer Diameter: 8 Millimeter
  • 8mm diameter dome
Z545005

  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z598321
In Commercial Distribution

  • 09321502038393 ()
  • 09321502043113 ()
Z598321

  • Earmould, preformed
N/A
COCHLEAR LIMITED
Z598322
In Commercial Distribution

  • 09321502038386 ()
  • 09321502043120 ()
Z598322

  • Earmould, preformed
No Description
W.H. Holden, Inc.
90-73OS-040HP
In Commercial Distribution

  • D9289073OS040HP0 ()


  • Carbide dental bur, reusable
No Description
AB MEDICA
C35-IP-2DS-33
In Commercial Distribution

  • E496C35IP2DS330 ()
C35-IP-2DS-33

  • Endoscopic electrosurgical electrode, monopolar, reusable
No Description
AB MEDICA
C35-IP-2DC-33
In Commercial Distribution

  • E496C35IP2DC330 ()
C35-IP-2DC-33

  • Endoscopic electrosurgical electrode, monopolar, reusable
STYLE 410, FM, 180G
Allergan, Inc.
FM-410180
Not in Commercial Distribution

  • 10888628002807 ()

  • 180 cc
FM-410180

  • Silicone gel-filled breast implant
STYLE 410, FM, 155G
Allergan, Inc.
FM-410155
Not in Commercial Distribution

  • 10888628002791 ()

  • 155 cc
FM-410155

  • Silicone gel-filled breast implant
STYLE 410, FF, 160G
Allergan, Inc.
FF-410160
Not in Commercial Distribution

  • 10888628002616 ()

  • 160 cc
FF-410160

  • Silicone gel-filled breast implant
No Description
TORNIER
CMI-14.5
In Commercial Distribution

  • 03700386941726 ()

  • Size LARGE
CMI-14,5

  • Carpometacarpal interpositional spacer, non-bioabsorbable
No Description
TORNIER
CMI-13
In Commercial Distribution

  • 03700386941719 ()

  • Size MEDIUM
CMI-13

  • Carpometacarpal interpositional spacer, non-bioabsorbable
No Description
TORNIER
CMI-12
In Commercial Distribution

  • 03700386941702 ()

  • Size SMALL
CMI-12

  • Carpometacarpal interpositional spacer, non-bioabsorbable
Sterile Cutting Board [20/case]
Scientific Device Laboratory, Inc.
905
In Commercial Distribution

  • 00810047420439 ()


  • Histology/pathology tissue cutting board IVD
Silicone Gel Breast Implant, Smooth Round, Moderate Plus Profile, 650 cc
Sientra, Inc.
10721-650MP
In Commercial Distribution

  • 00812790025916 ()

  • Volume: 650 cc
10721-650MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, Moderate Plus Profile, 590 cc
Sientra, Inc.
10721-590MP
In Commercial Distribution

  • 00812790025909 ()

  • Volume: 590 cc
10721-590MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, Moderate Plus Profile, 540 cc
Sientra, Inc.
10721-540MP
In Commercial Distribution

  • 00812790025893 ()

  • Volume: 540 cc
10721-540MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, Moderate Plus Profile, 505 cc
Sientra, Inc.
10721-505MP
In Commercial Distribution

  • 00812790025886 ()

  • Volume: 505 cc
10721-505MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, Moderate Plus Profile, 455 cc
Sientra, Inc.
10721-455MP
In Commercial Distribution

  • 00812790025879 ()

  • Volume: 455 cc
10721-455MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, Moderate Plus Profile, 415 cc
Sientra, Inc.
10721-415MP
In Commercial Distribution

  • 00812790025862 ()

  • Volume: 415 cc
10721-415MP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, High Profile, 700 cc
Sientra, Inc.
10721-700HP
In Commercial Distribution

  • 00812790025855 ()

  • Volume: 700 cc
10721-700HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, High Profile, 650 cc
Sientra, Inc.
10721-650HP
In Commercial Distribution

  • 00812790025848 ()

  • Volume: 650 cc
10721-650HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, High Profile, 620 cc
Sientra, Inc.
10721-620HP
In Commercial Distribution

  • 00812790025831 ()

  • Volume: 620 cc
10721-620HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, High Profile, 590 cc
Sientra, Inc.
10721-590HP
In Commercial Distribution

  • 00812790025824 ()

  • Volume: 590 cc
10721-590HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, High Profile, 535 cc
Sientra, Inc.
10721-535HP
In Commercial Distribution

  • 00812790025817 ()

  • Volume: 535 cc
10721-535HP

  • Silicone gel-filled breast implant
Silicone Gel Breast Implant, Smooth Round, High Profile, 470 cc
Sientra, Inc.
10721-470HP
In Commercial Distribution

  • 00812790025800 ()

  • Volume: 470 cc
10721-470HP

  • Silicone gel-filled breast implant
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