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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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KATANA™ Zirconia - EKUR1259004KA0

HTML PLUS T22 A3 C
KURARAY NORITAKE DENTAL INC.
125-9004KA
In Commercial Distribution

  • EKUR1259004KA0 ()

  • Outer Diameter: 98.5 Millimeter
  • Thickness: 22 Millimeter


  • Dental appliance fabrication material, ceramic

KATANA™ Zirconia - EKUR1258993KA0

HTML PLUS T18 A3 C
KURARAY NORITAKE DENTAL INC.
125-8993KA
In Commercial Distribution

  • EKUR1258993KA0 ()

  • Outer Diameter: 98.5 Millimeter
  • Thickness: 18 Millimeter


  • Dental appliance fabrication material, ceramic

KATANA™ Zirconia - EKUR1258982KA0

HTML PLUS T14 A3 C
KURARAY NORITAKE DENTAL INC.
125-8982KA
In Commercial Distribution

  • EKUR1258982KA0 ()

  • Outer Diameter: 98.5 Millimeter
  • Thickness: 14 Millimeter


  • Dental appliance fabrication material, ceramic

KATANA™ Zirconia - EKUR1258974KA0

HTML PLUS T22 A2 C
KURARAY NORITAKE DENTAL INC.
125-8974KA
In Commercial Distribution

  • EKUR1258974KA0 ()

  • Outer Diameter: 98.5 Millimeter
  • Thickness: 22 Millimeter


  • Dental appliance fabrication material, ceramic

KATANA™ Zirconia - EKUR1258963KA0

HTML PLUS T18 A2 C
KURARAY NORITAKE DENTAL INC.
125-8963KA
In Commercial Distribution

  • EKUR1258963KA0 ()

  • Outer Diameter: 98.5 Millimeter
  • Thickness: 18 Millimeter


  • Dental appliance fabrication material, ceramic

KATANA™ Zirconia - EKUR1258952KA0

HTML PLUS T14 A2 C
KURARAY NORITAKE DENTAL INC.
125-8952KA
In Commercial Distribution

  • EKUR1258952KA0 ()

  • Outer Diameter: 98.5 Millimeter
  • Thickness: 14 Millimeter


  • Dental appliance fabrication material, ceramic

KATANA™ Zirconia - EKUR1258944KA0

HTML PLUS T22 A1 C
KURARAY NORITAKE DENTAL INC.
125-8944KA
In Commercial Distribution

  • EKUR1258944KA0 ()

  • Outer Diameter: 98.5 Millimeter
  • Thickness: 22 Millimeter


  • Dental appliance fabrication material, ceramic

KATANA™ Zirconia - EKUR1258933KA0

HTML PLUS T18 A1 C
KURARAY NORITAKE DENTAL INC.
125-8933KA
In Commercial Distribution

  • EKUR1258933KA0 ()

  • Outer Diameter: 98.5 Millimeter
  • Thickness: 18 Millimeter


  • Dental appliance fabrication material, ceramic

KATANA™ Zirconia - EKUR1258922KA0

HTML PLUS T14 A1 C
KURARAY NORITAKE DENTAL INC.
125-8922KA
In Commercial Distribution

  • EKUR1258922KA0 ()

  • Outer Diameter: 98.5 Millimeter
  • Thickness: 14 Millimeter


  • Dental appliance fabrication material, ceramic

MC2 App - 00860008892744

No Description
OXOS Medical, Inc.
APP
In Commercial Distribution

  • 00860008892744 ()


  • Hand-held basic diagnostic x-ray system, digital

Hu-Friedy MFG Co., LLC - 10889950091187

#H5/GF21S SCALER DE
HU-FRIEDY MFG. CO., LLC
SC1393
In Commercial Distribution

  • 10889950091187 ()


  • Manual dental scaler, reusable

Hu-Friedy MFG Co., LLC - 10889950028275

#H5/U15 DE Scaler
HU-FRIEDY MFG. CO., LLC
SH5/U15
In Commercial Distribution

  • 10889950028275 ()


  • Manual dental scaler, reusable

Hu-Friedy MFG Co., LLC - 10889950028183

#H5/33 DE Scaler
HU-FRIEDY MFG. CO., LLC
SH5/33
In Commercial Distribution

  • 10889950028183 ()


  • Manual dental scaler, reusable

Hu-Friedy MFG Co., LLC. - 10889950106171

Dull Scaler H5/L4
HU-FRIEDY MFG. CO., LLC
DSH5/L46
In Commercial Distribution

  • 10889950106171 ()


  • Manual dental scaler, reusable

Hu-Friedy MFG Co., LLC. - 10889950103323

#H5/NEB128 Scaler EE2
HU-FRIEDY MFG. CO., LLC
SC6691E2
In Commercial Distribution

  • 10889950103323 ()


  • Periodontal curette

Power Dental USA - D94358980

PLUGGER 2.7mm/SCALER H5
Power Dental U.S.A. Inc.
5898
In Commercial Distribution

  • D94358980 ()
5898

  • Manual dental scaler, reusable
  • Dental excavator, reusable

Power Dental USA - D94312030

SCALERS JACQUETTE H5/33
Power Dental U.S.A. Inc.
1203
In Commercial Distribution

  • D94312030 ()
1203

  • Dental excavator, reusable
  • Manual dental scaler, reusable

Power Dental USA - D94312020

SCALERS TOWNER H5/U15
Power Dental U.S.A. Inc.
1202
In Commercial Distribution

  • D94312020 ()
1202

  • Dental excavator, reusable
  • Manual dental scaler, reusable

ROI-C - 03662663016346

ROI-C IMPLANT 12X15.5 H5
LDR Spine Usa, Inc.
MC1351P
In Commercial Distribution

  • 03662663016346 ()

  • Width: 15.5 Millimeter
  • Depth: 12 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile

ROI-C - 03662663016278

ROI-C IMPLANT 12X14 H5
LDR Spine Usa, Inc.
MC1341P
In Commercial Distribution

  • 03662663016278 ()

  • Width: 14 Millimeter
  • Depth: 12 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile

ROI-C - 03662663016209

ROI-C IMPLANT 14X17 H5
LDR Spine Usa, Inc.
MC1331P
In Commercial Distribution

  • 03662663016209 ()

  • Width: 17 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile

ROI-C - 03662663016131

ROI-C IMPLANT 14X15.5 H5
LDR Spine Usa, Inc.
MC1321P
In Commercial Distribution

  • 03662663016131 ()

  • Width: 15.5 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile

ROI-C - 03662663016063

ROI-C IMPLANT 14X14 H5
LDR Spine Usa, Inc.
MC1311P
In Commercial Distribution

  • 03662663016063 ()

  • Width: 14 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile

Henry Schein Acclean - 00304040184899

Acclean Scaler H5/Langer
HENRY SCHEIN, INC.
5703776
In Commercial Distribution

  • 00304040184899 ()
5703776

  • Manual dental scaler, reusable

BMT Medizintechnik GmbH - 04251725202170

SCALER TOWNER-JACQUETTE, #H5/33
BMT Medizintechnik GmbH
719-125
In Commercial Distribution

  • 04251725202170 ()
719-125

  • Bone curette, reusable

SAFCO - 00840018600805

Safco Scaler, H5/33
NORDENT MANUFACTURING INC
102-9916
In Commercial Distribution

  • 00840018600805 ()


  • Manual dental scaler, reusable

NORDENT MANUFACTURING INC - 00840018610736

SE SCALER #5 (H5)
NORDENT MANUFACTURING INC
SCN5
In Commercial Distribution

  • 00840018610736 ()


  • Manual dental scaler, reusable

J & J INSTRUMENTS - 00817524029468

LIGATURE DIRECTOR/ #H5 HOLLOW
J & J INSTRUMENTS INC
77-819
In Commercial Distribution

  • 00817524029468 ()


  • Orthodontic ligature director

J & J INSTRUMENTS - 00817524029178

SCALER #H5/33 HOLLOW
J & J INSTRUMENTS INC
71-533
In Commercial Distribution

  • 00817524029178 ()


  • Manual dental scaler, reusable

Surgical Direct - B382SD12290

Dental Scaler H5/5
Surgical Direct, Inc.
SD1229
In Commercial Distribution

  • B382SD12290 ()
SD1229

  • Dental elevator, tooth/root

Unimed - 06945664817660

SpO2 interface cable/安维生/3.0M/073/客户订做
Unimed Medical Supplies, Inc.
U710-172
In Commercial Distribution

  • 06945664817660 ()


  • Electrical-only medical device connection cable, reusable

KATANA Zirconia - 07630031753519

zerion® HTML 15-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753519 ()
010.0123

  • Dental bridge, ceramic

KATANA Zirconia - 07630031753502

zerion® HTML 14-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753502 ()
010.0122

  • Dental bridge, ceramic

KATANA Zirconia - 07630031753496

zerion® HTML 13-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753496 ()
010.0121

  • Dental bridge, ceramic

KATANA Zirconia - 07630031753489

zerion® HTML 12-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753489 ()
010.0120

  • Dental bridge, ceramic

KATANA Zirconia - 07630031753472

zerion® HTML 11-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753472 ()
010.0119

  • Dental bridge, ceramic

KATANA Zirconia - 07630031753465

zerion® HTML 10-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753465 ()
010.0118

  • Dental bridge, ceramic

KATANA Zirconia - 07630031753458

zerion® HTML 9-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753458 ()
010.0117

  • Dental bridge, ceramic

KATANA Zirconia - 07630031753441

zerion® HTML 8-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753441 ()
010.0116

  • Dental bridge, ceramic

KATANA Zirconia - 07630031753434

zerion® HTML 7-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753434 ()
010.0115

  • Dental bridge, ceramic

KATANA Zirconia - 07630031753427

zerion® HTML 6-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753427 ()
010.0114

  • Dental bridge, ceramic

KATANA Zirconia - 07630031753410

zerion® HTML 5-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753410 ()
010.0113

  • Dental bridge, ceramic

KATANA Zirconia - 07630031753403

zerion® HTML 4-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753403 ()
010.0112

  • Dental bridge, ceramic

KATANA Zirconia - 07630031753397

zerion® HTML 3-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753397 ()
010.0111

  • Dental bridge, ceramic

KATANA Zirconia - 07630031753380

zerion® HTML 2-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753380 ()
010.0110

  • Dental bridge, ceramic

KATANA Zirconia - 07630031753373

zerion® HTML single unit , xSHADEx
Institut Straumann AG
Crowns
In Commercial Distribution

  • 07630031753373 ()
010.0109

  • Custom-made dental crown, ceramic

KATANA Zirconia - 07630031753366

zerion® HTML 16-unit restoration, xSHADEx
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031753366 ()
010.0124

  • Dental bridge, ceramic

H5/33 Scaler - 00810060723449

No Description
Berman Instruments LLC
SS533
Not in Commercial Distribution

  • 00810060723449 ()


  • Manual dental scaler, reusable

H5/H6 Scaler - 00810060723425

No Description
Berman Instruments LLC
SS056
Not in Commercial Distribution

  • 00810060723425 ()


  • Manual dental scaler, reusable

StealthStation Cranial Software - 00643169865341

SW APP 9735762 STEALTH S8 APP
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00643169865341 ()


  • Multi-purpose stereotactic surgery system
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