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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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Amber® Mill Q - 08800057167082

No Description
Hass Corporation
Amber Mill Q HT C12/B2 (L)
In Commercial Distribution

  • 08800057180005 ()
  • 08800057167082 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057167068

No Description
Hass Corporation
Amber Mill Q HT C12/A4 (L)
In Commercial Distribution

  • 08800057179986 ()
  • 08800057167068 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057167044

No Description
Hass Corporation
Amber Mill Q HT C12/A3 (L)
In Commercial Distribution

  • 08800057179962 ()
  • 08800057167044 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057167037

No Description
Hass Corporation
Amber Mill Q HT C12/A2 (L)
In Commercial Distribution

  • 08800057179955 ()
  • 08800057167037 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057167020

No Description
Hass Corporation
Amber Mill Q HT C12/A1 (L)
In Commercial Distribution

  • 08800057179948 ()
  • 08800057167020 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057167013

No Description
Hass Corporation
Amber Mill Q HT C12/W4 (L)
In Commercial Distribution

  • 08800057179931 ()
  • 08800057167013 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057167006

No Description
Hass Corporation
Amber Mill Q HT C12/W3 (L)
In Commercial Distribution

  • 08800057179924 ()
  • 08800057167006 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057166986

No Description
Hass Corporation
Amber Mill Q HT C12/W1 (L)
In Commercial Distribution

  • 08800057179900 ()
  • 08800057166986 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057166962

No Description
Hass Corporation
Amber Mill Q HT+ C12/D3 (L)
In Commercial Distribution

  • 08800057180296 ()
  • 08800057166962 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057166948

No Description
Hass Corporation
Amber Mill Q HT+ C12/C4 (L)
In Commercial Distribution

  • 08800057180272 ()
  • 08800057166948 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057166931

No Description
Hass Corporation
Amber Mill Q HT+ C12/C3 (L)
In Commercial Distribution

  • 08800057180265 ()
  • 08800057166931 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057166917

No Description
Hass Corporation
Amber Mill Q HT+ C12/C1 (L)
In Commercial Distribution

  • 08800057180241 ()
  • 08800057166917 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057166887

No Description
Hass Corporation
Amber Mill Q HT+ C12/B2 (L)
In Commercial Distribution

  • 08800057180210 ()
  • 08800057166887 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057166863

No Description
Hass Corporation
Amber Mill Q HT+ C12/A4 (L)
In Commercial Distribution

  • 08800057180197 ()
  • 08800057166863 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057166849

No Description
Hass Corporation
Amber Mill Q HT+ C12/A3 (L)
In Commercial Distribution

  • 08800057180173 ()
  • 08800057166849 ()


  • Dental appliance fabrication material, ceramic

Amber® Mill Q - 08800057166818

No Description
Hass Corporation
Amber Mill Q HT+ C12/W4 (L)
In Commercial Distribution

  • 08800057180142 ()
  • 08800057166818 ()


  • Dental appliance fabrication material, ceramic

Q Distal Access Catheter - B293Q6691450

The MIVI Q Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The catheter shaft has a hydrophilic coating. The proximal portion of the catheter is a stainless-steel control wire.
MIVI NEUROVASCULAR
Q6-69145
In Commercial Distribution

  • B293Q6691450 ()

  • Length: 145 Centimeter
  • Catheter Gauge: 6 French


  • Vascular guide-catheter, single-use

Q Distal Access Catheter - B293Q5571450

The MIVI Q Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The catheter shaft has a hydrophilic coating. The proximal portion of the catheter is a stainless-steel control wire.
MIVI NEUROVASCULAR
Q5-57145
In Commercial Distribution

  • B293Q5571450 ()

  • Length: 145 Centimeter
  • Catheter Gauge: 5 French


  • Vascular guide-catheter, single-use

Q Distal Access Catheter - B293Q4431500

The MIVI Q Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The catheter shaft has a hydrophilic coating. The proximal portion of the catheter is a stainless-steel control wire.
MIVI NEUROVASCULAR
Q4-43150
In Commercial Distribution

  • B293Q4431500 ()

  • Catheter Gauge: 4 French
  • Length: 150 Centimeter


  • Vascular guide-catheter, single-use

Q Distal Access Catheter - B293Q3361630

The MIVI Q Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The catheter shaft has a hydrophilic coating. The proximal portion of the catheter is a stainless-steel control wire.
MIVI NEUROVASCULAR
Q3-36163
In Commercial Distribution

  • B293Q3361630 ()

  • Length: 163 Centimeter
  • Catheter Gauge: 3 French


  • Vascular guide-catheter, single-use

Poly Per Q Cath - 00801741095887

Catheter Placement Kit
Bard Access Systems, Inc.
CK000113A
In Commercial Distribution

  • 10801741095884 ()
  • 00801741095887 ()

  • Length: 60 Centimeter
  • Catheter Gauge: 4 French
CK000113A

  • Peripherally-inserted central venous catheter

Rotor-Gene® Q MDx - 04053228010838

No Description
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228010838 ()
9002035

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

physIQ Patient Kit - 00850023120144

physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparation materials.
PHYSIQ, INC
Model Q
In Commercial Distribution

  • 00850023120144 ()


  • Electrocardiography telemetric monitoring system

Revolution - 00195278923257

Revolution Maxima CT designated medical device
Hangwei GE Medical Systems Co., Ltd.
Maxima Q
In Commercial Distribution

  • 00195278923257 ()
RevolutionMaxima

  • Full-body CT system

N/A - 00618029870049

SALESMAN SAMPLES, Q Care Rx, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
9002-S
Not in Commercial Distribution

  • 50618029870044 ()
  • 00618029870049 ()
9002-S

  • Basic manual toothbrush
  • Oral care kit, single-use
  • Dental tooth-cleaning solution
  • Oral care swab
  • Dental suction system cannula, single-use

Q-Care - 00618029830715

Q Care, Q4 Oral Cleansing & Suctioning System, Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
6944
Not in Commercial Distribution

  • 50618029830710 ()
  • 00618029830715 ()
6944

  • Oral care kit, single-use
  • Dental suction system cannula, single-use
  • Oral care swab
  • Dental tooth-cleaning solution
  • Basic manual toothbrush

Q-Care - 00618029830333

Q Care, Q4 Oral Cleansing & Suctioning System, Suction Toothbrush Compatible with Chlorhexidine Gluconate(CHG) Oral Rinse
SAGE PRODUCTS, LLC
6924
Not in Commercial Distribution

  • 50618029830338 ()
  • 00618029830333 ()
6924

  • Oral care kit, single-use
  • Oral care swab
  • Dental tooth-cleaning solution
  • Dental suction system cannula, single-use
  • Basic manual toothbrush

Q-Care - 00618029830326

Q Care, Q2 Oral Cleansing & Suctioning System, Suction Toothbrush Compatible with Chlorhexidine Gluconate(CHG) Oral Rinse
SAGE PRODUCTS, LLC
6922
Not in Commercial Distribution

  • 50618029830321 ()
  • 00618029830326 ()
6922

  • Basic manual toothbrush
  • Dental tooth-cleaning solution
  • Oral care swab
  • Dental suction system cannula, single-use
  • Oral care kit, single-use

Quickie 2 - 00016958043815

The Quickie 2 Family of chairs are folding ultra lightweight manual wheelchairs that offer strong frames without sacrificing weight savings.
SUNRISE MEDICAL (US) LLC
Quickie 2, Quickie 2 Lite, Quickie 2 Lite 2.0
In Commercial Distribution

  • 00016958043815 ()
EIQ2X

  • Push-rim manual wheelchair, non-bariatric

Q-Care Rx - 00618029830128

Professional Sample- Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
6904-PS
In Commercial Distribution

  • 50618029830123 ()
  • 00618029830128 ()
6904-PS

  • Dental tooth-cleaning solution
  • Oral care kit, single-use
  • Oral care swab
  • Dental suction system cannula, single-use
  • Basic manual toothbrush

Q-Care Rx - 00618029830234

Professional Sales Sample- Q Care Rx, Q2, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
6912-PS
In Commercial Distribution

  • 50618029830239 ()
  • 00618029830234 ()
6912-PS

  • Oral care swab
  • Dental suction system cannula, single-use
  • Basic manual toothbrush
  • Oral care kit, single-use
  • Dental tooth-cleaning solution

Q-Care Rx - 00618029830227

Sales Demonstration Sample- Q Care Rx, Q2, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
6912-S
In Commercial Distribution

  • 50618029830222 ()
  • 00618029830227 ()
6912-S

  • Oral care swab
  • Dental suction system cannula, single-use
  • Basic manual toothbrush
  • Oral care kit, single-use
  • Dental tooth-cleaning solution

Q-Care Rx - 00618029830210

Professional Sales Sample- Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
6914-PS
In Commercial Distribution

  • 50618029830215 ()
  • 00618029830210 ()
6914-PS

  • Dental tooth-cleaning solution
  • Basic manual toothbrush
  • Oral care kit, single-use
  • Dental suction system cannula, single-use
  • Oral care swab

Q-Care Rx - 00618029830203

Sales Demonstration Sample- Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
6914-S
In Commercial Distribution

  • 50618029830208 ()
  • 00618029830203 ()
6914-S

  • Dental tooth-cleaning solution
  • Oral care swab
  • Dental suction system cannula, single-use
  • Basic manual toothbrush
  • Oral care kit, single-use

Q-Care Rx - 00618029830111

Sales Demonstration Sample, Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
SAGE PRODUCTS, LLC
6904-S
In Commercial Distribution

  • 50618029830116 ()
  • 00618029830111 ()
6904-S

  • Dental tooth-cleaning solution
  • Oral care swab
  • Dental suction system cannula, single-use
  • Basic manual toothbrush
  • Oral care kit, single-use

Warm Plate - 04589700010411

An Individual package we offer contains 10 plates. The package has product label and letters "Warm Plate-10 Plate" are written on it.
REPROLIFE INC.
WP010
In Commercial Distribution

  • 04589700010411 ()
  • 45897000122015 ()


  • Tissue cryostorage straw

Vitri Plate - 04589700010404

An Individual package we offer contains 10 plates. The package has product label and letters "Vitri Plate-10 Plate" are written on it.
REPROLIFE INC.
VP010
In Commercial Distribution

  • 04589700010404 ()
  • 45897000121018 ()


  • Tissue cryostorage straw

Bio-Eye® - 00854066006120

Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations, eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I0024P
In Commercial Distribution

  • 00854066006120 ()

  • Outer Diameter: 24 Millimeter


  • Orbital sphere implant
  • Orbital sphere implant wrap, non-biological
  • Ophthalmic conformer

Bio-Eye® - 00854066006113

Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I0022P
In Commercial Distribution

  • 00854066006113 ()

  • Outer Diameter: 22 Millimeter


  • Orbital sphere implant
  • Orbital sphere implant wrap, non-biological
  • Ophthalmic conformer

Bio-Eye® - 00854066006106

Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I0020P
In Commercial Distribution

  • 00854066006106 ()

  • Outer Diameter: 20 Millimeter


  • Orbital sphere implant wrap, non-biological
  • Orbital sphere implant
  • Ophthalmic conformer

Bio-Eye® - 00854066006090

Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I0018P
In Commercial Distribution

  • 00854066006090 ()

  • Outer Diameter: 18 Millimeter


  • Orbital sphere implant wrap, non-biological
  • Orbital sphere implant
  • Ophthalmic conformer

Bio-Eye® - 00854066006076

Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I0022C
In Commercial Distribution

  • 00854066006076 ()

  • Outer Diameter: 22 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant wrap, non-biological
  • Orbital sphere implant

Bio-Eye® - 00854066006069

Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I0020C
In Commercial Distribution

  • 00854066006069 ()

  • Outer Diameter: 20 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant wrap, non-biological
  • Orbital sphere implant

Bio-Eye® - 00854066006052

Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I0018C
In Commercial Distribution

  • 00854066006052 ()

  • Outer Diameter: 18 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant wrap, non-biological
  • Orbital sphere implant

Bio-Eye® - 00854066006083

Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I0016P
In Commercial Distribution

  • 00854066006083 ()

  • Outer Diameter: 16 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant wrap, non-biological
  • Orbital sphere implant

LZI Norfentanyl (Q) Qualitative Calibrator - 00850624008360

NFEN Cutoff Calibrator 5 ng/mL (1 x 5 mL)
LIN-ZHI INTERNATIONAL, INC.
C68815
In Commercial Distribution

  • 00850624008360 ()
C68815

  • Fentanyl IVD, calibrator

LZI Fentanyl (Q) Enzyme Immunoassay - 00850624008353

Antibody/Substrate Reagent (R1): 100 mL Enzyme Conjugate Reagent (R2): 37.5 mL
LIN-ZHI INTERNATIONAL, INC.
C68808
In Commercial Distribution

  • 00850624008353 ()
C68808

  • Fentanyl IVD, kit, enzyme immunoassay (EIA)

Optimus Drill Q - 3.5mm 40mm - 09348215031862

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-013
In Commercial Distribution

  • 09348215031862 ()


  • Fluted surgical drill bit, reusable

Optimus Drill Q – 3.7mm 20mm - 09348215061807

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-076
In Commercial Distribution

  • 09348215061807 ()


  • Fluted surgical drill bit, reusable

Optimus Drill Q – 4.5mm 40mm - 09348215061784

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-070
In Commercial Distribution

  • 09348215061784 ()


  • Fluted surgical drill bit, reusable
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