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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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Earlens Tympanic Lens - 00850013007097

Tympanic Lens L- left, R - Right
EARLENS CORPORATION
TLEL1X
Not in Commercial Distribution

  • 00850013007097 ()
TLEL1X

  • Tympanic membrane contact hearing aid tympanic transducer

Earlens Processor & Light Tip - 00850013007073

Kit containing 1 Processor and 1 LIght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown LT comes in L - Left, R - Right
EARLENS CORPORATION
PLEL1X
Not in Commercial Distribution

  • 00850013007073 ()
PLEL1X

  • Tympanic membrane contact hearing aid ear tip transmitter
  • Tympanic membrane contact hearing aid sound processor

Earlens Light Tip - 00850013007066

Light Tip w/ left & right packaged
EARLENS CORPORATION
LTEL1LR
Not in Commercial Distribution

  • 00850013007066 ()
  • 00850013007165 ()
LTEL1LR

  • Tympanic membrane contact hearing aid ear tip transmitter

Earlens Light Tip - 00850013007059

Light Tip comes in L - Left, R - Right
EARLENS CORPORATION
LTEL1X
Not in Commercial Distribution

  • 00850013007059 ()
LTEL1X

  • Tympanic membrane contact hearing aid ear tip transmitter

Earlens ELF USB - 00850013007042

Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF001
Not in Commercial Distribution

  • 00850013007042 ()
ELF001

  • Audiometric/hearing device software

Earlens Charger - 00850013007035

No Description
EARLENS CORPORATION
CHEL101
In Commercial Distribution

  • 00850013007035 ()
CHEL101

  • Noninvasive device battery charger

Earlens Processor - 00850013007011

Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black
EARLENS CORPORATION
PREL1XX
Not in Commercial Distribution

  • 00850013007011 ()
PREL1XX

  • Tympanic membrane contact hearing aid sound processor

GUI - 00850012978015

Lightweight, battery-powered ultrasound system with dual-array fingertip transducer. Transducer incorporated a high-frequency liner array and a low-frequency phased array.
SONIVATE MEDICAL, INC.
SDA-001
In Commercial Distribution

  • 00850012978015 ()


  • Hand-held ultrasound imaging system, body-surface

SonicEye® Dual-Array Ultrasound System - 00850012978008

Lightweight, battery-powered ultrasound system with dual-array fingertip transducer. Transducer incorporated a high-frequency liner array and a low-frequency phased array.
SONIVATE MEDICAL, INC.
SDA-001
In Commercial Distribution

  • 00850012978008 ()


  • Hand-held ultrasound imaging system, body-surface

BRITEVIEW - 00850012936923

Color-coded disposable LED laryngoscope blade (Miller 4 - Lime)
Hartwell Medical LLC
LB 51MIL4-DS
In Commercial Distribution

  • 10850012936920 ()
  • 00850012936923 ()

  • Miller 4
LB 51MIL4-DS

  • Laryngoscope blade, single-use

GRANDVIEW - 00850012936695

Disposable laryngoscope blade (Adult)
Hartwell Medical LLC
GV 2020A-DS
In Commercial Distribution

  • 10850012936692 ()
  • 00850012936695 ()

  • Adult
GV 2020A-DS

  • Laryngoscope blade, single-use

GRANDVIEW - 00850012936664

Standard laryngoscope handle (medium)
Hartwell Medical LLC
GV 1002
In Commercial Distribution

  • 00850012936664 ()

  • Medium
GV 1002

  • Laryngoscope handle, reusable

GRANDVIEW - 00850012936657

Standard laryngoscope handle (small)
Hartwell Medical LLC
GV 1001
In Commercial Distribution

  • 00850012936657 ()

  • Small
GV 1001

  • Laryngoscope handle, reusable

BRITEVIEW - 00850012936091

Color-coded disposable LED laryngoscope blade (Miller 3 - Orange)
Hartwell Medical LLC
LB 51MIL3-DS
In Commercial Distribution

  • 10850012936098 ()
  • 00850012936091 ()

  • Miller 3
LB 51MIL3-DS

  • Laryngoscope blade, single-use

BRITEVIEW - 00850012936084

Color-coded disposable LED laryngoscope blade (Miller 2 - Yellow)
Hartwell Medical LLC
LB 51MIL2-DS
In Commercial Distribution

  • 10850012936081 ()
  • 00850012936084 ()

  • Miller 2
LB 51MIL2-DS

  • Laryngoscope blade, single-use

BRITEVIEW - 00850012936077

Color-coded disposable LED laryngoscope blade (Miller 1 - Pink)
Hartwell Medical LLC
LB 51MIL1-DS
In Commercial Distribution

  • 10850012936074 ()
  • 00850012936077 ()
LB 51MIL1-DS

  • Laryngoscope blade, single-use

BRITEVIEW - 00850012936060

Color-coded disposable LED laryngoscope blade (Miller 0 - White)
Hartwell Medical LLC
LB 51MIL0-DS
In Commercial Distribution

  • 10850012936067 ()
  • 00850012936060 ()

  • Miller 0
LB 51MIL0-DS

  • Laryngoscope blade, single-use

BRITEVIEW - 00850012936053

Color-coded disposable LED laryngoscope blade (Macintosh 4 - Lime)
Hartwell Medical LLC
LB 51MAC4-DS
In Commercial Distribution

  • 10850012936050 ()
  • 00850012936053 ()

  • Macintosh 4
LB 51MAC4-DS

  • Laryngoscope blade, single-use

BRITEVIEW - 00850012936046

Color-coded disposable LED laryngoscope blade (Macintosh 3 - Orange)
Hartwell Medical LLC
LB 51MAC3-DS
In Commercial Distribution

  • 10850012936043 ()
  • 00850012936046 ()

  • Macintosh 3
LB 51MAC3-DS

  • Laryngoscope blade, single-use

BRITEVIEW - 00850012936039

Color-coded disposable LED laryngoscope blade (Macintosh 2 - Yellow)
Hartwell Medical LLC
LB 51MAC2-DS
In Commercial Distribution

  • 10850012936036 ()
  • 00850012936039 ()

  • Macintosh 2
LB 51MAC2-DS

  • Laryngoscope blade, single-use

BRITEVIEW - 00850012936022

Color-coded disposable LED laryngoscope blade (Macintosh 1 - Pink)
Hartwell Medical LLC
LB 51MAC1-DS
In Commercial Distribution

  • 10850012936029 ()
  • 00850012936022 ()

  • Macintosh 1
LB 51MAC1-DS

  • Laryngoscope blade, single-use

JNW URTRAC - 00850012846451

JNW URTRAC INSTRUMENT GUIDE
LSI Solutions, Inc.
081300
In Commercial Distribution

  • 10850012846458 ()
  • 00850012846451 ()
081300

  • Endoscope sheath, single-use

COR-KNOT MICRO - 00850012846420

COR-KNOT® MICRO Twin Pack
LSI Solutions, Inc.
032760
In Commercial Distribution

  • 10850012846427 ()
  • 00850012846420 ()
  • 00850012846444 ()
032760

  • Suture clasp, non-bioabsorbable

multiSTATION™ - 00850012846413

5MM Cannula with Obturator
LSI Solutions, Inc.
081890
In Commercial Distribution

  • 00850012846413 ()
081890

  • Pleuroscopic/mediastinoscopic access cannula, reusable

multiSTATION™ - 00850012846406

Cannula Adapter
LSI Solutions, Inc.
080415
In Commercial Distribution

  • 00850012846406 ()
080415

  • Pleuroscopic/mediastinoscopic access cannula, reusable

multiSTATION™ - 00850012846390

RITA RetroSterno™ Paddle
LSI Solutions, Inc.
081880
In Commercial Distribution

  • 00850012846390 ()
081880

  • Surgical retractor/retraction system blade, reusable

multiSTATION™ - 00850012846383

LITA RetroSterno™ Paddle
LSI Solutions, Inc.
081870
In Commercial Distribution

  • 00850012846383 ()
081870

  • Surgical retractor/retraction system blade, reusable

multiSTATION™ - 00850012846376

10mm COUPLER
LSI Solutions, Inc.
080550
In Commercial Distribution

  • 00850012846376 ()
080550

  • Surgical instrument assist arm system structural component

multiSTATION™ - 00850012846369

DOC-X 45™ EXTENDER
LSI Solutions, Inc.
080780
In Commercial Distribution

  • 00850012846369 ()
080780

  • Surgical instrument assist arm system structural component

multiSTATION™ - 00850012846352

DOC-X 25™ EXTENDER
LSI Solutions, Inc.
080770
In Commercial Distribution

  • 00850012846352 ()
080770

  • Surgical instrument assist arm system structural component
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