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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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MEDPOR - 07613252083375

Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6317
In Commercial Distribution

  • 07613252083375 ()

  • Diameter: 20.0 Millimeter
6317

  • Orbital sphere implant

MEDPOR - 07613252170297

Malar Implant Teardrop Standard
Stryker Leibinger GmbH & Co. KG
6323
In Commercial Distribution

  • 07613252170297 ()

  • Length: 30.0 Millimeter
  • Diameter: 5.6 Millimeter
6323

  • Orbital sphere implant

Fisher & Paykel Healthcare - 09420012427069

F&P Pilairo Q Nasal Pillows Mask
FISHER & PAYKEL HEALTHCARE LIMITED
400421
In Commercial Distribution

  • 09420012427076 ()
  • 09420012427069 ()
400421

  • CPAP/BPAP nasal mask, reusable

Fisher & Paykel Healthcare - 09420012425546

Zest Q Plus Nasal Mask (Sleep Lab)
FISHER & PAYKEL HEALTHCARE LIMITED
400446SL
In Commercial Distribution

  • 09420012425546 ()
  • 09420012427335 ()
400446SL

  • CPAP/BPAP nasal mask, reusable

Fisher & Paykel Healthcare - 09420012425539

Zest Q Standard Nasal Mask (Sleep Lab)
FISHER & PAYKEL HEALTHCARE LIMITED
400445SL
In Commercial Distribution

  • 09420012427328 ()
  • 09420012425539 ()
400445SL

  • CPAP/BPAP nasal mask, reusable

Fisher & Paykel Healthcare - 09420012425522

Zest Q Petite Nasal Mask (Sleep Lab)
FISHER & PAYKEL HEALTHCARE LIMITED
400444SL
In Commercial Distribution

  • 09420012427311 ()
  • 09420012425522 ()
400444SL

  • CPAP/BPAP nasal mask, reusable

N/A - 00613994481115

SFTWR KIT 9733933XOM DICOM SOFTWARE Q/R
MEDTRONIC NAVIGATION, INC.
9733933XOM
In Commercial Distribution

  • 00613994481115 ()


  • Multi-purpose stereotactic surgery system

N/A - 00613994467072

SFTWR KIT 9733933 DICOM SOFTWARE Q/R
MEDTRONIC NAVIGATION, INC.
9733933
In Commercial Distribution

  • 00613994467072 ()


  • Multi-purpose stereotactic surgery system

Q Pedicle Instruments - 10888857553385

Everest MI XT Q Tap, Cannulated Ø8.5mm
K2M, INC.
48112985
In Commercial Distribution

  • 10888857553385 ()
48112985

  • Bone tap, reusable

Q Pedicle Instruments - 10888857553378

Everest MI XT Q Tap, Cannulated Ø7.5mm
K2M, INC.
48112975
In Commercial Distribution

  • 10888857553378 ()
48112975

  • Bone tap, reusable

Q Pedicle Instruments - 10888857553361

Everest MI XT Q Tap, Cannulated Ø6.5mm
K2M, INC.
48112965
In Commercial Distribution

  • 10888857553361 ()
48112965

  • Bone tap, reusable

Q Pedicle Instruments - 10888857553354

Everest MI XT Q Tap, Cannulated Ø5.5mm
K2M, INC.
48112955
In Commercial Distribution

  • 10888857553354 ()
48112955

  • Bone tap, reusable

Q Pedicle Instruments - 10888857553347

Everest MI XT Q Tap, Cannulated Ø4.5mm
K2M, INC.
48112945
In Commercial Distribution

  • 10888857553347 ()
48112945

  • Bone tap, reusable

Q Pedicle Instruments - 10888857552371

Xia 3/Serrato/ES2 Q Drive Shaft
K2M, INC.
48113201
In Commercial Distribution

  • 10888857552371 ()
48113201

  • Surgical screwdriver, reusable

IMS - 10889950067175

8x10.5 16 INST Q CASSETTE, OCEAN BLUE
HU-FRIEDY MFG. CO., LLC
IMN41611Q
Not in Commercial Distribution

  • 10889950067175 ()
IMN41611Q

  • Device sterilization/disinfection container, reusable

IMS - 10889950066840

8X10.5 12 INST Q CASSETTE, OCEAN BLUE
HU-FRIEDY MFG. CO., LLC
IMN41211Q
Not in Commercial Distribution

  • 10889950066840 ()
IMN41211Q

  • Device sterilization/disinfection container, reusable

Medtronic Reusable Instruments - 00681490912235

INSTRUMENT 922502S Q C STRT PED SPATULA
MEDTRONIC SOFAMOR DANEK, INC.
922502S
In Commercial Distribution

  • 00681490912235 ()


  • General-purpose surgical spatula

Medtronic Reusable Instruments - 00681490912211

INSTRUMENT 922501L Q C LONG SQUARE AWL
MEDTRONIC SOFAMOR DANEK, INC.
922501L
In Commercial Distribution

  • 00681490912211 ()


  • Bone awl, reusable

Medtronic Reusable Instruments - 00681490912204

INSTRUMENT 922501S Q C SHORT SQUARE AWL
MEDTRONIC SOFAMOR DANEK, INC.
922501S
In Commercial Distribution

  • 00681490912204 ()


  • Bone awl, reusable

SIGNIA - 04056839027493

HA LPL EAR Q S2 SP BG
Ws Audiology Usa, Inc.
EAR Q I2 SP
In Commercial Distribution

  • 04056839027493 ()
10943054

  • Air-conduction hearing aid, behind-the-ear
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