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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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Quantum - 05060434422521

Quantum Workstation 15 Elite
SPECTRUM MEDICAL LIMITED
QWS15E
In Commercial Distribution

  • 05060434422521 ()
51-000100-00

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434422279

Quantum Workstation 15" Lite
SPECTRUM MEDICAL LIMITED
QWS15L
In Commercial Distribution

  • 05060434422279 ()
51-000091-00

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434422026

Quantum Workstation Lite - 15"
SPECTRUM MEDICAL LIMITED
QWSL
In Commercial Distribution

  • 05060434422026 ()
51-000080-00

  • Cardiopulmonary bypass system roller pump

ALEUTIAN Interbody Systems - 10888857127807

Chisel Size 15 mm
K2M, INC.
702-90158
In Commercial Distribution

  • 10888857127807 ()
702-90158

  • Orthopaedic chisel

Power Dental U.S.A., Inc. - D943N1218

JACQUETTE SCALERS J14/15
Power Dental U.S.A. Inc.
N1218
Not in Commercial Distribution

  • D943N1218 ()
N1218

  • Manual dental scaler, reusable

Odontit - D914RAPA150

preangulated 15 w/screw
ODONTIT S.A.
RA-PA15
In Commercial Distribution

  • D914RAPA150 ()
RA-PA15

  • Screw endosteal dental implant, two-piece

rexpander - D894BE240

rexpander 3.6 x 15
Rex Implants, Inc.
3.6 x 15
In Commercial Distribution

  • D894BE240 ()

  • Height: 15 Millimeter
  • Width: 3.6 Millimeter
BE-24

  • Maxillofacial bone separator

rexpander - D894BE200

rexpander 3.2 x 15
Rex Implants, Inc.
3.2 x 15
In Commercial Distribution

  • D894BE200 ()

  • Height: 15 Millimeter
  • Width: 3.2 Millimeter
BE-20

  • Maxillofacial bone separator

rexpander - D894BE120

rexpander 2.4 x 15
Rex Implants, Inc.
2.4 x 15
In Commercial Distribution

  • D894BE120 ()

  • Height: 15 Millimeter
  • Width: 2.4 Millimeter
BE-12

  • Maxillofacial bone separator

rexpander - D894BE160

rexpander 2.8 x 15
Rex Implants, Inc.
2.8 x 15
In Commercial Distribution

  • D894BE160 ()

  • Height: 15 Millimeter
  • Width: 2.8 Millimeter
BE-16

  • Maxillofacial bone separator

rexpander - D894BE080

rexpander 2.0 x 15
Rex Implants, Inc.
2.0 x 15
In Commercial Distribution

  • D894BE080 ()

  • Height: 15 Millimeter
  • Width: 2.0 Millimeter
BE-08

  • Maxillofacial bone separator

rexpander - D894BE040

rexpander 1.6 x 15
Rex Implants, Inc.
1.6 x 15
In Commercial Distribution

  • D894BE040 ()

  • Height: 15 Millimeter
  • Width: 1.6 Millimeter
BE-04

  • Maxillofacial bone separator

U-KneeTec - 05056139230325

Spacer 9 - 15 mm
CORIN LTD
MVV659
In Commercial Distribution

  • 05056139230325 ()
MVV659

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Genemed® - 00615233006905

AEC, Ready-To-Use, 15 mL
SAKURA FINETEK U.S.A., INC.
10-0047
In Commercial Distribution

  • 00615233006905 ()
10-0047

  • Chromogenic/colorimetric substrate reagent IVD

N/A - 04961333244232

CBL,4BNC-4BNC,15 VIDEO
PENTAX OF AMERICA, INC.
PV-MVC/15
In Commercial Distribution

  • 04961333244232 ()

  • Length: 15.0 Feet


  • Radiology information system

PenBlade - 00618125190966

#15 Safety Scalpel, Sterile
TIDI PRODUCTS, LLC
PB-M-15
In Commercial Distribution

  • 20618125190960 ()
  • 00618125190966 ()
  • 30618125190967 ()
  • 10853624005022 ()
  • 10618125190963 ()
PB-M-15

  • Scalpel, single-use

BioHorizons - 00847236017217

MILO 15° Angle Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
MLAA15Z
In Commercial Distribution

  • 00847236017217 ()


  • Dental implant suprastructure, permanent, preformed

BioHorizons - 00847236014667

MDL 15° Cementable Abutment
BIOHORIZONS IMPLANT SYSTEMS, INC
MDLAA15Z
In Commercial Distribution

  • 00847236014667 ()


  • Dental implant suprastructure, permanent, preformed

Sharpoint - 00848782027323

15 DEG. MICROKNIFE - 3MM
Surgical Specialties México, S. de R.L. de C.V.
72-1531
In Commercial Distribution

  • 10848782027320 ()
  • 00848782027323 ()

  • 3MM


  • Scalpel, single-use

Sharpoint - 00848782027309

15° Stab Knife Straight
Surgical Specialties México, S. de R.L. de C.V.
72-1501G
In Commercial Distribution

  • 10848782027306 ()
  • 00848782027309 ()

  • 15 degree
72-1501G

  • Ophthalmic knife, single-use

REMEL - 00848838001215

Chocolate Agar 15/PK
REMEL, INC.
R01301
Not in Commercial Distribution

  • 00848838001215 ()
R01301

  • General-microorganism antimicrobial susceptibility culture medium IVD

REMEL - 00848838003516

XLD Agar 15/PK
REMEL, INC.
R01981
In Commercial Distribution

  • 00848838003516 ()
R01981

  • Differential/selective agar culture medium IVD

Disposable Safety Scalpel - 00620974002468

#15 Sterile Safety Scalpel
Southmedic Incorporated
73-0615
In Commercial Distribution

  • 10620974002465 ()
  • 00620974002468 ()
  • 20620974002462 ()
73-0615

  • Scalpel, single-use

Disposable Scalpel - 00620974002192

#15 Sterile Disposable Scalpel
Southmedic Incorporated
73-0115
In Commercial Distribution

  • 10620974002199 ()
  • 00620974002192 ()
  • 20620974002196 ()
73-0115

  • Scalpel, single-use

PRO-SIL - 00852260000296

Pro-Sil SPF 15 17g
Biodermis LLC
PROSP17-111
In Commercial Distribution

  • 00852260000296 ()
PROSP17-111

  • Scar-management dressing, reusable

PRO-SIL - 00852260000289

Pro-Sil SPF 15 4.25g
Biodermis LLC
PROSP-111
In Commercial Distribution

  • 00852260000289 ()
PROSP-111

  • Scar-management dressing, reusable

DabirAir Accessories - 00851343006330

15' Power Cord Accessory
DABIR SURFACES, INC.
GA-90B2-15
In Commercial Distribution

  • 00851343006330 ()

  • Length: 15 Feet


  • Basic power supply, reusable

LifeVue - 00851455007959

CRYOCATH, 15" LIFEVUE, V3C-X15-R210,
Nds Surgical Imaging LLC
90X0701
In Commercial Distribution

  • 00851455007959 ()


  • Image display unit, colour

Aleutian Interbody System - 10888857413214

Modular Trial Size 15
K2M, INC.
SP-3099-09
Not in Commercial Distribution

  • 10888857413214 ()
SP-3099-09

  • General internal orthopaedic fixation system implantation kit

NIAGARA® Lateral Access System - 10888857436084

Extended Driver Size 15
K2M, INC.
AC01-90065
In Commercial Distribution

  • 10888857436084 ()
AC01-90065

  • Orthopaedic implant driver

HU-FRIEDY - 10889950085513

15 DE AMALGAM PLUGGER
HU-FRIEDY MFG. CO., LLC
PLG1339
In Commercial Distribution

  • 10889950085513 ()
PLG1339

  • Endodontic plugger

Planatome® - 00860003857847

Planatome Ultra-Fine #15 Scalpel
Planatome, LLC
UF-15
In Commercial Distribution

  • 00860003857854 ()
  • 00860003857847 ()
  • 00860003857878 ()

  • Weight: .413 Gram


  • Manual scalpel blade, single-use

NovaChat - 00858526006941

NC8.5 Keyguard 15 location
PRENTKE ROMICH COMPANY
20062-15
In Commercial Distribution

  • 00858526006941 ()

  • Length: 7.94 Inch
  • Width: 4.42 Inch
  • Height: .18 Inch


  • Voice synthesizer/digitizer

Hydrotherapy Whirlpool - 00645724001379

MIDLAND HYDROCONVERTIBLE, 15 GAL
Whitehall Manufacturing Co
E-15-M-HC
In Commercial Distribution

  • 00645724001379 ()
E-15-M-HC

  • Hydro-massage turbine
  • Hydrotherapy bath/tank

Conformis Hip System - 00850268007798

BROACH, FEMORAL, SIZE 15
Conformis, Inc.
1080-578
In Commercial Distribution

  • 00850268007798 ()

  • Outer Diameter: 15 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards) - 00857275007124

15 THC test dip-cards
IDUN SOLUTIONS LLC
IDTH-115-15P
Not in Commercial Distribution

  • 00857275007124 ()
  • 00857275007025 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

FRESNEL PRISM AND LENS - 00850029104216

TRIAL RING - 15 DIOPTER
Fresnel Prism & Lens Company
4000-15
In Commercial Distribution

  • 00850029104216 ()
4000-15

  • Trial lens set

multiSTATION™ - 00850012846253

DOC-X 15™ EXTENDER
LSI Solutions, Inc.
081370
In Commercial Distribution

  • 00850012846253 ()
081370

  • Surgical instrument assist arm system structural component

CHESAPEAKE Stabilization System - 10888857297265

Distractor Size 15 mm
K2M, INC.
SP-1566-05
In Commercial Distribution

  • 10888857297265 ()

  • Height: 15 Millimeter
SP-1566-05

  • Orthopaedic prosthesis implantation positioning instrument, reusable

ALEUTIAN® Interbody Systems - 10888857248212

Osteotome, Size 15 mm
K2M, INC.
SP-1605-03
In Commercial Distribution

  • 10888857248212 ()

  • Width: 15 Millimeter
SP-1605-03

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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