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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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Young - 00302730511000

Young Prophy Cup, Soft, Long, Gray Web Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
051100
In Commercial Distribution

  • 10302730511007 ()
  • 00302730511000 ()
051100

  • Dental polishing cup, single-use

Young - 00302730510003

Young Junior Prophy Cup, Soft, Long, Gray Web Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
051000
In Commercial Distribution

  • 10302730510000 ()
  • 00302730510003 ()
051000

  • Dental polishing cup, single-use

Young - 00302730503005

Young Prophy Cup, Firm, Long, White Ribbed Cup, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
050300
In Commercial Distribution

  • 10302730503002 ()
  • 00302730503005 ()
050300

  • Dental polishing cup, single-use

Young - 00302730501001

Young Ribbed Prophy Cup, Soft, Long, Gray Ribbed Cup, Screw type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
050100
In Commercial Distribution

  • 10302730501008 ()
  • 00302730501001 ()
050100

  • Dental polishing cup, single-use

DELL FIXATION RING - 00841668128497

DELL FIXATION RING
KATENA PRODUCTS, INC.
AE-2186
In Commercial Distribution

  • 00841668128497 ()
AE-2186

  • Eyeball fixation instrument, reusable

Mrk, Ocular - 00841668119952

Dell Swivel Toric Mark. W/Rotating Bezel
KATENA PRODUCTS, INC.
08-12120
In Commercial Distribution

  • 00841668119952 ()
08-12120

  • Corneal marker, reusable

Mrk, Ocular - 00841668119945

Dell Fixed Toric Mark. W/ Rotating Bezel
KATENA PRODUCTS, INC.
08-12119
In Commercial Distribution

  • 00841668119945 ()
08-12119

  • Corneal marker, reusable

Mrk, Ocular - 00841668119891

Dell Astigmatism Marker, (Nichamin)
KATENA PRODUCTS, INC.
08-121115
In Commercial Distribution

  • 00841668119891 ()
08-121115

  • Corneal marker, reusable

Mrk, Ocular - 00841668119853

Dell Astigmatism Marker, 6 & 8mm Cord
KATENA PRODUCTS, INC.
08-121085
In Commercial Distribution

  • 00841668119853 ()

  • Length: 8 Millimeter
  • Length: 6 Millimeter
08-121085

  • Corneal marker, reusable

Mrk, Ocular - 00841668119846

Dell Astigmatism Marker
KATENA PRODUCTS, INC.
08-12108
In Commercial Distribution

  • 00841668119846 ()
08-12108

  • Corneal marker, reusable

Vapotherm - 00841737105831

HVT 2.0 Buy Out Unit
VAPOTHERM, INC.
HVT-BUYOUT
In Commercial Distribution

  • 00841737105831 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
  • Professional high-flow respiratory unit, humidifying, manual

CARDINAL HEALTH - 10888439679892

GENERAL LAPAROSCOPY PACK
Cardinal Health 200, LLC
SBA23CHBUY
In Commercial Distribution

  • 50888439679890 ()
  • 10888439679892 ()
SBA23CHBUY

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

CARDINAL HEALTH - 10888439621464

KIT, C SECTION
Cardinal Health 200, LLC
PL23CSBUY
In Commercial Distribution

  • 50888439621462 ()
  • 10888439621464 ()
PL23CSBUY

  • Obstetrical/gynaecological surgical procedure kit, medicated

NA - 00841983104183

No Audio Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6804-7460
Not in Commercial Distribution

  • 00841983104183 ()
RNS-6804-7460

  • Centralized patient monitor

NA - 00841983104176

Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6803-7460
Not in Commercial Distribution

  • 00841983104176 ()
RNS-6803-7460

  • Centralized patient monitor

NEUROFAX - 00841983103971

NEUROFAX ACQUISITION, Dell Precision Tower desktop
NIHON KOHDEN AMERICA, INC.
EEG-1200A-T
In Commercial Distribution

  • 00841983103971 ()
EEG-1200A-T

  • Electroencephalograph

Panda In-Bed Scale - 00840682143721

ASSY-LAU, PANDA IN-BED SCALE, Finished good - Buy
Datex-Ohmeda, Inc.
PS1
In Commercial Distribution

  • 00840682143721 ()


  • Infant scale, electronic

Giraffe EU In-Bed Scale - 00840682143714

ASSY-LAU, GIRAFFE IN-BED SCALE EU, Finished good - Buy
DATEX-OHMEDA INC
GS EU1
Not in Commercial Distribution

  • 00840682143714 ()


  • Infant scale, electronic

Giraffe In-Bed Scale - 00840682143677

ASSY-LAU, GIRAFFE IN-BED SCALE, Finished good - Buy
Datex-Ohmeda, Inc.
GS1
In Commercial Distribution

  • 00840682143677 ()


  • Infant scale, electronic

Panda EU In-Bed Scale - 00840682143660

ASSY-LAU, PANDA IN-BED SCALE EU, Finished good - Buy
DATEX-OHMEDA INC
PS EU1
Not in Commercial Distribution

  • 00840682143660 ()


  • Infant scale, electronic

AADCO - 00840348505283

AMSTRON AP-1222OEV BATTERY MUST BUY TWO
AADCO MEDICAL, INC.
OSP-AP12220EV
In Commercial Distribution

  • 00840348505283 ()
OSP-AP12220EV

  • Custom-made medical device mount

Innomed, Inc. - 00840277122803

IHS Inclinometer (Della Valle Inclinometer)
INNOMED, INC.
1326
In Commercial Distribution

  • 00840277122803 ()
1326

  • Surgical drill guide, reusable

Ambler Surgical - 00190660104245

Dell LRI astigmatism marker (Nichamin Nomogram), 4 3/4'', 40/60/80 degree markings, rotating ring with degree markings, round handle, titanium
AMBLER SURGICAL CORP.
Dell LRI astigmatism marker (Nichamin Nomogram)
In Commercial Distribution

  • 00190660104245 ()
8302T

  • Scleral marker, reusable

Ambler Surgical - 00190660104238

Dell LRI astigmatism marker (Gills Nomogram), 4 3/4'', marks chord length of 6.0mm and 8.0mm, rotating ring with degree markings, round handle, titanium
AMBLER SURGICAL CORP.
Dell LRI astigmatism marker (Gills Nomogram)
In Commercial Distribution

  • 00190660104238 ()
8301T

  • Scleral marker, reusable

ORDOCK CUP, DISPOSABLE - B99214101010

A SINGLE, STERILE CUP THAT ATTACHES TO A PLATFORM (NOT INCLUDED) TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE. THIS CUP IS SOLD SINGLY TO ACCOMMODATE HOSPITALS WHO WISH TO BUY IN BULK. HOWEVER TWO CUPS ARE REQUIRED TO BE ATTACHED TO THE PLATFORM WHEN IT IS BEING USED.
JB Medical Development, LLC
14-101-01
In Commercial Distribution

  • B99214101010 ()
1410101

  • Surgical instrument interim-placement holder, single-use

PLANNING STATION-ROSA ONE- USA - 03760244035127

planning station DELL 3560 QUERTY power plug B for Rosa One 3.1.5
MEDTECH
164050
In Commercial Distribution

  • 03760244035127 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system

PLANNING STATION-ROSA ONE- USA - 03760244034922

planning station DELL 3560 Querty power plug B for Rosa One 3.1.6
MEDTECH
164050
In Commercial Distribution

  • 03760244034922 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system

PLANNING STATION Rosa One - 03760244033840

planning station DELL 7520 Querty power plug B for Rosa One 3.1.4.0
MEDTECH
164017
In Commercial Distribution

  • 03760244033840 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system

PLANNING STATION Rosa One - 03760244032652

planning station DELL 7520 Querty power plug B for Rosa One 3.1.1.0
MEDTECH
164017-00
Not in Commercial Distribution

  • 03760244032652 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system

PLANNING STATION Rosa One -USA - 03760244034403

planning station DELL 7520 Querty power plug B for Rosa One 3.1.5 (Brain application)
MEDTECH
164017
In Commercial Distribution

  • 03760244034403 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system

ROSA PLANNING STATION - 03760244030375

ROSA PLANNING STATION Laptop computer with the following minimal configuration : Windows 7, intel Pentium processor, 15,6'' screen, DVD +/- RW, USB ports, 25GB graphics card, eternet connection for PACS interface with graphical user interface for surgical planning, pre-operative navigation and frameless streotaxy.
MEDTECH
DELL 7520
Not in Commercial Distribution

  • 03760244030375 ()
ROSAS00369

  • Multi-purpose stereotactic surgery system
  • Neurological stereotactic surgery system

PLANNING STATION - ROSA ONE - USA - 00889024671102

Planning Station DELL 7520 Qwerty power plug B for Rosa One
MEDTECH
164017-02
In Commercial Distribution

  • 00889024671102 ()


  • Multi-purpose stereotactic surgery system

Colour touch screen Dell 24 Touch monitor- P2418HT - 60.5 cm (23.8) Black ITL - D800KT004118

Colour touch screen Dell 24 Touch monitor- P2418HT - 60.5 cm (23.8) Black ITL for Zirkonzahn scanner
ZIRKONZAHN SRL
KT004118
In Commercial Distribution

  • D800KT004118 ()


  • Dental milling system, CAD/CAM, laboratory

Integra® Miltex® - 10381780462200

Luxating Elevator Kit, Set of 8: C2 - C5 and S2 - S5, With Cassette
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
DELLUXKIT
Not in Commercial Distribution

  • H834DELLUXKIT1 ()
  • 10381780462200 ()
DELLUXKIT

  • Dental elevator, tooth/root

DJO SURGICAL - 00888912440998

RSP, BASEPLATE RIM PLANER 40MM* DO NOT BUY
Encore Medical, L.P.
804-03-035
In Commercial Distribution

  • 00888912440998 ()


  • Bone-resection orthopaedic reamer, reusable

Millennium - 00190776200282

DELL ASTIGMATISM MARKER GILLS and
Avalign Technologies, Inc.
92-CM01302
In Commercial Distribution

  • 00190776200282 ()


  • Corneal marker, reusable

LRI/Toric Markers - 08175700109505

LRI Marker, 6mm & 8mm Chord Lengths, With Degree Gauge (Uses Dell/Gills Nomograms)
AURORA SURGICAL, LLC
AS3-500
In Commercial Distribution

  • 08175700109505 ()
AS3-500

  • Ophthalmic angular gauge, reusable

Laptop - D800WRAB5161

Laptop Instructor DELL 7710 (Trade Show)
ZIRKONZAHN SRL
WRAB5161
In Commercial Distribution

  • D800WRAB5161 ()


  • Dental milling system, CAD/CAM, laboratory

Surgical Direct - B382SD9228701020

11 1/2 inch Brown Delloid Retractor Small, 57 mm Blade Width
Surgical Direct, Inc.
SD922870102
In Commercial Distribution

  • B382SD9228701020 ()
SD922870102

  • Self-retaining surgical retractor, reusable

Surgical Direct - B382SD9228701010

11 1/2 inch Brown Delloid Retractor Small, 45mm Blade Width
Surgical Direct, Inc.
SD922870101
In Commercial Distribution

  • B382SD9228701010 ()
SD922870101

  • Self-retaining surgical retractor, reusable
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