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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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14mm Sterile Orbital Implant (PMMA) - B091142520

No Description
Gulden Ophthalmics Inc.
14252
In Commercial Distribution

  • B091142520 ()

  • Outer Diameter: 14 Millimeter
14252

  • Orbital sphere implant

12mm Sterile Orbital Implant (PMMA) - B091142510

No Description
Gulden Ophthalmics Inc.
14251
In Commercial Distribution

  • B091142510 ()

  • Outer Diameter: 12 Millimeter
14251

  • Orbital sphere implant

10mm Sterile Orbital Implant (PMMA) - B091142500

No Description
Gulden Ophthalmics Inc.
14250
In Commercial Distribution

  • B091142500 ()

  • Outer Diameter: 10 Millimeter
14250

  • Orbital sphere implant

22mm Eye Sphere (non-sterile) - B091141561

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14156
In Commercial Distribution

  • B091141561 ()
  • B091141560 ()

  • Outer Diameter: 22 Millimeter
14156

  • Orbital sphere implant

22mm Eye Sphere (non-sterile) - B091141560

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14156
In Commercial Distribution

  • B091141560 ()

  • Outer Diameter: 22 Millimeter
14156

  • Orbital sphere implant

20mm Eye Sphere (non-sterile) - B091141551

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14155
In Commercial Distribution

  • B091141551 ()
  • B091141550 ()

  • Outer Diameter: 20 Millimeter
14155

  • Orbital sphere implant

20mm Eye Sphere (non-sterile) - B091141550

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14155
In Commercial Distribution

  • B091141550 ()

  • Outer Diameter: 20 Millimeter
14155

  • Orbital sphere implant

18mm Eye Sphere (non-sterile) - B091141541

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14154
In Commercial Distribution

  • B091141541 ()
  • B091141540 ()

  • Outer Diameter: 18 Millimeter
14154

  • Orbital sphere implant

18mm Eye Sphere (non-sterile) - B091141540

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14154
In Commercial Distribution

  • B091141540 ()

  • Outer Diameter: 18 Millimeter
14154

  • Orbital sphere implant

16mm Eye Sphere (non-sterile) - B091141531

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14153
In Commercial Distribution

  • B091141531 ()
  • B091141530 ()

  • Outer Diameter: 16 Millimeter
14153

  • Orbital sphere implant

16mm Eye Sphere (non-sterile) - B091141530

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14153
In Commercial Distribution

  • B091141530 ()

  • Outer Diameter: 16 Millimeter
14153

  • Orbital sphere implant

14mm Eye Sphere (non-sterile) - B091141521

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14152
In Commercial Distribution

  • B091141521 ()
  • B091141520 ()

  • Outer Diameter: 14 Millimeter
14152

  • Orbital sphere implant

14mm Eye Sphere (non-sterile) - B091141520

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14152
In Commercial Distribution

  • B091141520 ()

  • Outer Diameter: 14 Millimeter
14152

  • Orbital sphere implant

12mm Eye Sphere (non-sterile) - B091141511

Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14151
In Commercial Distribution

  • B091141511 ()
  • B091141510 ()

  • Outer Diameter: 12 Millimeter
14151

  • Orbital sphere implant

12mm Eye Sphere (non-sterile) - B091141510

Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14151
In Commercial Distribution

  • B091141510 ()

  • Outer Diameter: 12 Millimeter
14151

  • Orbital sphere implant

10mm Eye Sphere (non-sterile) - B091141501

Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14150
In Commercial Distribution

  • B091141501 ()
  • B091141500 ()

  • Outer Diameter: 10 Millimeter
14150

  • Orbital sphere implant

10mm Eye Sphere (non-sterile) - B091141500

Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14150
In Commercial Distribution

  • B091141500 ()

  • Outer Diameter: 10 Millimeter
14150

  • Orbital sphere implant

MEDPOR - 07613252084044

MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
80010
In Commercial Distribution

  • 07613252084044 ()

  • Diameter: 18.0 Millimeter
80010

  • Orbital sphere implant

MEDPOR - 07613252083405

Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6327
In Commercial Distribution

  • 07613252083405 ()

  • Diameter: 18.0 Millimeter
6327

  • Orbital sphere implant

MEDPOR - 07613252083399

Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6326
In Commercial Distribution

  • 07613252083399 ()

  • Diameter: 16.0 Millimeter
6326

  • Orbital sphere implant

MEDPOR - 07613252083382

Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6316
In Commercial Distribution

  • 07613252083382 ()

  • Diameter: 14.0 Millimeter
6316

  • Orbital sphere implant

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

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 - 00681490912204

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

  • 00681490912204 ()


  • Bone awl, 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 - 00681490912211

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

  • 00681490912211 ()


  • 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

SIGNIA - 04056839027486

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

  • 04056839027486 ()
10943055

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

SIGNIA - 04056839027479

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

  • 04056839027479 ()
10943056

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

SIGNIA - 04056839027462

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

  • 04056839027462 ()
10943057

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

SIGNIA - 04056839027455

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

  • 04056839027455 ()
10943058

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

SIGNIA - 04056839027448

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

  • 04056839027448 ()
10943059

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

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

De Soutter Medical - 05051471140417

GQ-707 DRILL & REAM COMBI HEAD - Q OUTPUT
DE SOUTTER MEDICAL LIMITED
17570
In Commercial Distribution

  • 05051471140417 ()
17570

  • Drilling power tool attachment, basic
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