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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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ContourFlex™ Gluteal Implant, Smooth (Round) - M724CCB5S541

Gluteal Implant
IMPLANTECH ASSOCIATES, INC.
Size: 14.0cm x 14.0cm x 4.2cm
In Commercial Distribution

  • M724CCB5S541 ()
CCB5-S-54

  • Silicone-block tissue reconstructive material

ContourFlex™ Gluteal Implant, Smooth (Round) - M724CCB5S521

Gluteal Implant
IMPLANTECH ASSOCIATES, INC.
Size: 12.6cm x 12.6cm x 3.7cm
In Commercial Distribution

  • M724CCB5S521 ()
CCB5-S-52

  • Silicone-block tissue reconstructive material

Control Samples US - 07332699000737

No Description
M DIALYSIS INC.
5 x Low, 5 x Elevated
In Commercial Distribution

  • 07332699000737 ()
8010306

  • Microdialysis system

Glucose reagent - 07332699000652

No Description
M DIALYSIS INC.
5 x Reagent, 5 x Buffer
In Commercial Distribution

  • 07332699000652 ()
P000023

  • Microdialysis system

Pyruvate reagent - 07332699000324

No Description
M DIALYSIS INC.
5 x Reagent, 5 x Buffer
In Commercial Distribution

  • 07332699000324 ()
P000063

  • Microdialysis system

Lactate reagent - 07332699000317

No Description
M DIALYSIS INC.
5 x Reagent, 5 x Buffer
In Commercial Distribution

  • 07332699000317 ()
P000024

  • Microdialysis system

Glycerol reagent - 07332699000294

No Description
M DIALYSIS INC.
5 x Reagent, 5 x Buffer
In Commercial Distribution

  • 07332699000294 ()
P000025

  • Microdialysis system

Glutamate reagent - 07332699000287

No Description
M DIALYSIS INC.
5 x Reagent, 5 x Buffer
In Commercial Distribution

  • 07332699000287 ()
P000064

  • Microdialysis system

ArtiFascia® - 07290019685005

ArtiFascia® is an absorbable dural repair graft for the repair of cranial dural defects. ArtiFascia® is a highly flexible, easy to handle, non-friable soft matrix composed of synthetic non-woven fibers and a non-porous film. ArtiFascia® readily conforms to the surface of the wound area and is applied to the dural defect by using sutures.
NURAMI MEDICAL LTD
3cm X 4cm (1.18" X 1.57")
In Commercial Distribution

  • 07290019685005 ()

  • 3cm X 4cm (1.18 Inches X 1.57 Inches)
ART3401

  • Dura mater graft, synthetic

ArtiFascia® - 07290019685029

ArtiFascia® is an absorbable dural repair graft for the repair of cranial dural defects. ArtiFascia® is a highly flexible, easy to handle, non-friable soft matrix composed of synthetic non-woven fibers and a non-porous film. ArtiFascia® readily conforms to the surface of the wound area and is applied to the dural defect by using sutures.
NURAMI MEDICAL LTD
7cm X 7cm (2.75" X 2.75")
In Commercial Distribution

  • 07290019685029 ()

  • 7cm X 7cm (2.75 Inches X 2.75 Inches)
ART7701

  • Dura mater graft, synthetic

ArtiFascia® - 07290019685012

ArtiFascia® is an absorbable dural repair graft for the repair of cranial dural defects. ArtiFascia® is a highly flexible, easy to handle, non-friable soft matrix composed of synthetic non-woven fibers and a non-porous film. ArtiFascia® readily conforms to the surface of the wound area and is applied to the dural defect by using sutures.
NURAMI MEDICAL LTD
5cm X 5cm (1.96" X 1.96")
In Commercial Distribution

  • 07290019685012 ()

  • 5cm X 5cm (1.96 Inches X 1.96 Inches)
ART5501

  • Dura mater graft, synthetic

IMPROSAFE® Blood Collection Set with Pre-Attached Holder - 06974481831078

No Description
Guangzhou Improve Medical Instruments Co., Ltd.
23G x 3/4” x 7”
In Commercial Distribution

  • 16974481831075 ()
  • 06974481831078 ()
  • 46974481831076 ()
  • 56974481831073 ()
  • 26974481831072 ()
  • 76974481831077 ()


  • Non-fixed blood collection needle

IMPROSAFE® Blood Collection Set with Pre-Attached Holder - 06974481831030

No Description
Guangzhou Improve Medical Instruments Co., Ltd.
23G x 3/4” x 12”
In Commercial Distribution

  • 16974481831037 ()
  • 06974481831030 ()
  • 26974481831034 ()
  • 76974481831039 ()
  • 46974481831038 ()
  • 56974481831035 ()


  • Non-fixed blood collection needle

IMPROSAFE® Blood Collection Set - 06974481831009

No Description
Guangzhou Improve Medical Instruments Co., Ltd.
25G x 3/4” x 7”
In Commercial Distribution

  • 16974481831006 ()
  • 06974481831009 ()
  • 26974481831003 ()
  • 86974481831005 ()
  • 46974481831007 ()
  • 56974481831004 ()
  • 66974481831001 ()
  • 76974481831008 ()
  • 96974481831002 ()


  • Non-fixed blood collection needle

IMPROSAFE® Blood Collection Set - 06974481830996

No Description
Guangzhou Improve Medical Instruments Co., Ltd.
23G x 3/4” x 7”
In Commercial Distribution

  • 16974481830993 ()
  • 06974481830996 ()
  • 26974481830990 ()
  • 86974481830992 ()
  • 46974481830994 ()
  • 56974481830991 ()
  • 66974481830998 ()
  • 76974481830995 ()
  • 96974481830999 ()


  • Non-fixed blood collection needle

IMPROSAFE® Blood Collection Set - 06974481830965

No Description
Guangzhou Improve Medical Instruments Co., Ltd.
25G x 3/4” x 12”
In Commercial Distribution

  • 16974481830962 ()
  • 06974481830965 ()
  • 26974481830969 ()
  • 86974481830961 ()
  • 46974481830963 ()
  • 56974481830960 ()
  • 66974481830967 ()
  • 76974481830964 ()
  • 96974481830968 ()


  • Non-fixed blood collection needle

IMPROSAFE® Blood Collection Set - 06974481830958

No Description
Guangzhou Improve Medical Instruments Co., Ltd.
23G x 3/4” x 12”
In Commercial Distribution

  • 06974481830958 ()
  • 16974481830955 ()
  • 46974481830956 ()
  • 56974481830953 ()
  • 66974481830950 ()
  • 76974481830957 ()
  • 96974481830951 ()
  • 26974481830952 ()
  • 86974481830954 ()


  • Non-fixed blood collection needle

Avaline Medical NJ LLC - 00850025452724

Split Drain Sponge 4x4 6 Ply 50 plus Tape
Avaline Medical NJ Limited Liability Company
4611 x 1 + VT
In Commercial Distribution

  • 00810077212493 ()
  • 00850025452724 ()
4611 x 1 + VT

  • Non-woven gauze pad

Avaline Medical NJ LLC - 00850025452588

Combine Abdominal Pads 8x10 20 plus Tape
Avaline Medical NJ Limited Liability Company
5810 x 1 +vp
In Commercial Distribution

  • 00810077212455 ()
  • 00850025452588 ()
5810 x 1 +vp

  • Non-woven gauze pad

TatumSurgical/Screw Implant - 00083208540202

Screw Dental Implant 4.0mm in diameter and 20mm in length
Suncoast Dental, Inc
Screw/4.0 x 20
In Commercial Distribution

  • 00083208540202 ()

  • Screw 4.0mm Diameter x 20mm Length
  • Outer Diameter: 4 Millimeter
  • Length: 20 Millimeter
IS 4.0 x 20mm

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208540141

Screw Dental Implant 4.0mm in diameter and 14mm in length
Suncoast Dental, Inc
Screw/4.0 x 14
In Commercial Distribution

  • 00083208540141 ()

  • Screw 4.0mm Diameter x 14mm Length
  • Outer Diameter: 4 Millimeter
  • Length: 14 Millimeter
IS 4.0 x 14mm

  • Screw endosteal dental implant, two-piece

Tatum Surgical/IP 5.0 x 11.0mm - 00083208501197

Press Fit Implant 5.0 x 11.0mm x 3mm Well Morse Taper
Suncoast Dental, Inc
IP 5.0 x 11.0mm
In Commercial Distribution

  • 00083208501197 ()

  • Press Fit Implant 5.0 x 11.0mm x 3mm Well Morse Taper
  • Outer Diameter: 5 Millimeter
  • Height: 11 Millimeter
IP 5.0 x 11.0mm

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208440205

4.0 mm Neck Diameter x 20 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
Integrity/4.0 x 20
In Commercial Distribution

  • 00083208440205 ()

  • Length: 20 Millimeter
  • Outer Diameter: 4 Millimeter
  • Integrity 4.0mm Diameter x 20mm Length
ITI 4.0 x 20

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208440175

4.0 mm Neck Diameter x 17 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
Integrity/4.0 x 17
In Commercial Distribution

  • 00083208440175 ()

  • Length: 17 Millimeter
  • Outer Diameter: 4 Millimeter
  • Integrity 4.0mm Diameter x 17mm Length
ITI 4.0 x 17

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208440144

4.0 mm Neck Diameter x 14 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
Integrity/4.0 x 14
In Commercial Distribution

  • 00083208440144 ()

  • Length: 14 Millimeter
  • Outer Diameter: 4 Millimeter
  • Integrity 4.0mm Diameter x 14mm Length
ITI 4.0 x 14

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208440113

4.0 mm Neck Diameter x 11 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
Integrity/4.0 x 11
In Commercial Distribution

  • 00083208440113 ()

  • Integrity 4.0mm Diameter x 11mm Length
  • Outer Diameter: 4 Millimeter
  • Length: 11 Millimeter
ITI 4.0 x 11

  • Screw endosteal dental implant, two-piece

Tatum Surgical/ITI 4.0 x 9mm - 00083208440090

4.0 mm Neck Diameter x 9 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
ITI 4.0 x 9mm
Not in Commercial Distribution

  • 00083208440090 ()

  • Outer Diameter: 4 Millimeter
  • Integrity Dental Implant 4.0mm in diameter and 9mm in length
  • Height: 9 Millimeter
ITI 4.0 x 09

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208437205

3.7 mm Neck Diameter x 20 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
Integrity/3.7 x 20
In Commercial Distribution

  • 00083208437205 ()

  • Outer Diameter: 3.7 Millimeter
  • Length: 20 Millimeter
  • Integrity 3.7mm Diameter x 20mm Length
ITI 3.7 x 20

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208437175

3.7 mm Neck Diameter x 17 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
Integrity/3.7 x 17
In Commercial Distribution

  • 00083208437175 ()

  • Integrity 3.7mm Diameter x 17mm Length
  • Length: 17 Millimeter
  • Outer Diameter: 3.7 Millimeter
ITI 3.7 x 17

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208437144

3.7 mm Neck Diameter x 14 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
Integrity/3.7 x 14
In Commercial Distribution

  • 00083208437144 ()

  • Outer Diameter: 3.7 Millimeter
  • Integrity 3.7mm Diameter x 14mm Length
  • Length: 14 Millimeter
ITI 3.7 x 14

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208437113

3.7 mm Neck Diameter x 11 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
Integrity/3.7 x 11
In Commercial Distribution

  • 00083208437113 ()

  • Integrity 3.7mm Diameter x 11mm Length
  • Length: 11 Millimeter
  • Outer Diameter: 3.7 Millimeter
ITI 3.7 x 11

  • Screw endosteal dental implant, two-piece

Tatum Surgical/ITI 3.7 x 9mm - 00083208437090

3.7mm Neck Diameter x 09mm Length. Integrity Dental Implant
Suncoast Dental, Inc
ITI 3.7 x 9mm
Not in Commercial Distribution

  • 00083208437090 ()

  • Height: 9 Millimeter
  • Outer Diameter: 3.7 Millimeter
  • Integrity Dental Implant 3.7mm in diameter and 9mm in length
ITI 3.7 x 09

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208409806

8.0 mm Neck Diameter x 9 mm Length. Integrity Dental Implant.
Suncoast Dental, Inc
Integrity/8.0 x 9
In Commercial Distribution

  • 00083208409806 ()

  • Length: 9 Millimeter
  • Integrity 8.0mm Diameter x 9mm Length
  • Outer Diameter: 8 Millimeter
ITI 8.0 x 09

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208409707

7.0 mm Neck Diameter x 9 mm Length. Integrity Dental Implant.
Suncoast Dental, Inc
Integrity/7.0 x 9
In Commercial Distribution

  • 00083208409707 ()

  • Length: 9 Millimeter
  • Integrity 7.0mm Diameter x 9mm Length
  • Outer Diameter: 7 Millimeter
ITI 7.0 x 09

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208409608

6.0 mm Neck Diameter x 9 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
Integrity/6.0 x 9
In Commercial Distribution

  • 00083208409608 ()

  • Integrity 6.0mm Diameter x 9mm Length
  • Outer Diameter: 6 Millimeter
  • Length: 9 Millimeter
ITI 6.0 x 09

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208409509

5.0 mm Neck Diameter x 9 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
Integrity/5.0 x 9
In Commercial Distribution

  • 00083208409509 ()

  • Integrity 5.0mm Diameter x 9mm Length
  • Outer Diameter: 5 Millimeter
  • Length: 9 Millimeter
ITI 5.0 x 09

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208409455

4.5 mm Neck Diameter x 9 mm in Length. Integrity Dental Implant
Suncoast Dental, Inc
Integrity/4.5 x 9
In Commercial Distribution

  • 00083208409455 ()

  • Length: 9 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Integrity 4.5mm Diameter x 9mm Length
ITI 4.5 x 09

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208409400

4.0 mm Neck Diameter x 9 mm Length. Integrity Dental Implant
Suncoast Dental, Inc
Integrity/4.0 x 9
In Commercial Distribution

  • 00083208409400 ()

  • Integrity 4.0mm Diameter x 9mm Length
  • Outer Diameter: 4 Millimeter
  • Length: 9 Millimeter
ITI 4.0 x 09

  • Screw endosteal dental implant, two-piece

Tatum Surgical/Integrity Implant - 00083208409370

3.7mm Neck Diameter x 9 mm length Integrity Dental Implant
Suncoast Dental, Inc
Integrity/3.7 x 9
In Commercial Distribution

  • 00083208409370 ()

  • Integrity 3.7mm Diameter x 9mm Length
  • Length: 9 Millimeter
  • Outer Diameter: 3.7 Millimeter
ITI 3.7 x 09

  • Screw endosteal dental implant, two-piece

TatumSurgical/Screw Implant - 00083208580147

Screw Dental Implant 8.0mm in diameter and 14mm in length
Suncoast Dental, Inc
Screw/8.0 x 14
In Commercial Distribution

  • 00083208580147 ()

  • Outer Diameter: 8 Millimeter
  • Length: 14 Millimeter
  • Screw 8.0mm Diameter x 14mm Length
IS 8.0 x 14mm

  • Screw endosteal dental implant, two-piece
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