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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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Bio-Eye® - 00854066006045

Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I00024S
In Commercial Distribution

  • 00854066006045 ()

  • Outer Diameter: 24 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant

Bio-Eye® - 00854066006038

Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I00022S
In Commercial Distribution

  • 00854066006038 ()

  • Outer Diameter: 22 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant

Bio-Eye® - 00854066006021

Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I00020S
In Commercial Distribution

  • 00854066006021 ()

  • Outer Diameter: 20 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant

Bio-Eye® - 00854066006014

Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I00018S
In Commercial Distribution

  • 00854066006014 ()

  • Outer Diameter: 18 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant

Bio-Eye® - 00854066006007

Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I00016S
In Commercial Distribution

  • 00854066006007 ()

  • Outer Diameter: 16 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant

Optimus Q Long - 09348215061753

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-045
In Commercial Distribution

  • 09348215061753 ()


  • Fluted surgical drill bit, reusable

Artis Q biplane - 04056869009995

No Description
Siemens Healthcare GmbH
10848282
In Commercial Distribution

  • 04056869009995 ()


  • Stationary angiographic x-ray system, digital

Artis Q ceiling - 04056869009988

No Description
Siemens Healthcare GmbH
10848281
In Commercial Distribution

  • 04056869009988 ()


  • Stationary angiographic x-ray system, digital

Artis Q floor - 04056869009971

No Description
Siemens Healthcare GmbH
10848280
In Commercial Distribution

  • 04056869009971 ()


  • Stationary angiographic x-ray system, digital

9185 Q Facebow - D040343581

A facebow is a device intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This is a reusable device.
WHIP-MIX CORPORATION
9185Q
In Commercial Distribution

  • D040343581 ()
9185Q

  • Facebow

2240 Q Articulator - D040342201

A dental articulator is a device designed to simulate all or part of the mandibular movements and used for examination, diagnosis, or to construct dental appliances. This is a reusable device.
WHIP-MIX CORPORATION
34220
In Commercial Distribution

  • D040342201 ()
34220

  • Dental articulator

2240 Q Articulator - D040342191

A dental articulator is a device designed to simulate all or part of the mandibular movements and used for examination, diagnosis, or to construct dental appliances. This is a reusable device.
WHIP-MIX CORPORATION
34219
In Commercial Distribution

  • D040342191 ()
34219

  • Dental articulator

4641 Q Articulator - D040022791

A dental articulator is a device designed to simulate all or part of the mandibular movements and used for examination, diagnosis, or to construct dental appliances. This is a reusable device.
WHIP-MIX CORPORATION
02279
In Commercial Distribution

  • D040022791 ()
02279

  • Dental articulator

4640 Q Articulator - D040022461

A dental articulator is a device designed to simulate all or part of the mandibular movements and used for examination, diagnosis, or to construct dental appliances. This is a reusable device.
WHIP-MIX CORPORATION
02276
In Commercial Distribution

  • D040022461 ()
02276

  • Dental articulator

R2 STUDIO Q - 08809708755005

No Description
Megagen Implant Co. Ltd
RCT820-SC
In Commercial Distribution

  • 08809708755005 ()
RCT820-SC

  • Stationary panoramic/tomographic dental x-ray system, digital

R2 STUDIO Q - 08809708752622

No Description
Megagen Implant Co. Ltd
RCT820
In Commercial Distribution

  • 08809708752622 ()
RCT820

  • Stationary panoramic/tomographic dental x-ray system, digital

Q System Arthroscope - 00813892021424

3mm 70º Non-Locking Arthroscope
Orthopedic Sciences Inc
AS-370
In Commercial Distribution

  • 00813892021424 ()

  • Outer Diameter: 3 Millimeter
AS-370

  • Rigid optical arthroscope, reusable

Q System Arthroscope - 00813892021110

3mm 30º Non-Locking Arthroscope
Orthopedic Sciences Inc
AS-330
In Commercial Distribution

  • 00813892021110 ()

  • Outer Diameter: 3 Millimeter
AS-330

  • Rigid optical arthroscope, reusable

Q System Arthroscope - 00813892021103

3mm 0º Non-Locking Arthroscope
Orthopedic Sciences Inc
AS-300
In Commercial Distribution

  • 00813892021103 ()

  • Outer Diameter: 3 Millimeter
AS-300

  • Rigid optical arthroscope, reusable

Q System Arthroscope - 00813892021097

3mm 30º Arthroscope
Orthopedic Sciences Inc
AS-175S
In Commercial Distribution

  • 00813892021097 ()

  • Outer Diameter: 3 Millimeter
AS-175S

  • Rigid optical arthroscope, reusable

Q System Arthroscope - 00813892021080

4mm 0º Long Arthroscope
Orthopedic Sciences Inc
AS-400
In Commercial Distribution

  • 00813892021080 ()

  • Outer Diameter: 4 Millimeter
AS-400

  • Rigid optical arthroscope, reusable

Q System Arthroscope - 00813892020670

5mm 70º Arthroscope
Orthopedic Sciences Inc
AS-570
In Commercial Distribution

  • 00813892020670 ()

  • Outer Diameter: 5 Millimeter
AS-570

  • Rigid optical arthroscope, reusable

Q System Arthroscope - 00813892020663

4mm 30º Long Arthroscope
Orthopedic Sciences Inc
AS-230
In Commercial Distribution

  • 00813892020663 ()

  • Outer Diameter: 4 Millimeter
AS-230

  • Rigid optical arthroscope, reusable

Q System Arthroscope - 00813892020656

3mm 30º Arthroscope
Orthopedic Sciences Inc
AS-175
In Commercial Distribution

  • 00813892020656 ()

  • Outer Diameter: 3 Millimeter
AS-175

  • Rigid optical arthroscope, reusable

Q System Arthroscope - 00813892020649

3mm 70º Arthroscope
Orthopedic Sciences Inc
AS-070
In Commercial Distribution

  • 00813892020649 ()

  • Outer Diameter: 3 Millimeter
AS-070

  • Rigid optical arthroscope, reusable

Q System Arthroscope - 00813892020632

5mm 30º Arthroscope
Orthopedic Sciences Inc
AS-050
In Commercial Distribution

  • 00813892020632 ()

  • Outer Diameter: 5 Millimeter
AS-050

  • Rigid optical arthroscope, reusable

Custom I Q - D798CIQA0

INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is the Part A of the two part system.
RELIANCE ORTHODONTIC PRODUCTS INC
CIQA
Not in Commercial Distribution

  • D798CIQA0 ()
CIQA

  • Dentine bonding agent/set

Mono Q® - 00810020088854

Suture
RIVERPOINT MEDICAL, LLC
Q1525
In Commercial Distribution

  • 10810020088851 ()
  • 00810020088854 ()


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Mono Q® - 00810020088847

Suture
RIVERPOINT MEDICAL, LLC
Q1520
In Commercial Distribution

  • 10810020088844 ()
  • 00810020088847 ()


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Mono Q® - 00810020088830

Suture
RIVERPOINT MEDICAL, LLC
Q1515
In Commercial Distribution

  • 10810020088837 ()
  • 00810020088830 ()


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
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