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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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ZCA® - 00889024638662

No Description
Zimmer, Inc.
8005-548-28
In Commercial Distribution

  • 00889024638662 ()

  • O.D. Cup With Spacers 51 mm
  • Lumen/Inner Diameter: 28.00 Millimeter
00-8005-548-28

  • Polyethylene acetabulum prosthesis

ZCA® - 00889024638655

No Description
Zimmer, Inc.
8005-548-26
In Commercial Distribution

  • 00889024638655 ()

  • Lumen/Inner Diameter: 26.00 Millimeter
  • O.D. Cup With Spacers 51 mm
00-8005-548-26

  • Polyethylene acetabulum prosthesis

ZCA® - 00889024638648

No Description
Zimmer, Inc.
8005-548-22
In Commercial Distribution

  • 00889024638648 ()

  • Lumen/Inner Diameter: 22.00 Millimeter
  • O.D. Cup With Spacers 51 mm
00-8005-548-22

  • Polyethylene acetabulum prosthesis

ZCA® - 00889024638631

No Description
Zimmer, Inc.
8005-546-32
In Commercial Distribution

  • 00889024638631 ()

  • O.D. Cup With Spacers 49 mm
  • Lumen/Inner Diameter: 32.00 Millimeter
00-8005-546-32

  • Polyethylene acetabulum prosthesis

ZCA® - 00889024638624

No Description
Zimmer, Inc.
8005-546-28
In Commercial Distribution

  • 00889024638624 ()

  • O.D. Cup With Spacers 49 mm
  • Lumen/Inner Diameter: 28.00 Millimeter
00-8005-546-28

  • Polyethylene acetabulum prosthesis

ZCA® - 00889024638617

No Description
Zimmer, Inc.
8005-546-26
In Commercial Distribution

  • 00889024638617 ()

  • Lumen/Inner Diameter: 26.00 Millimeter
  • O.D. Cup With Spacers 49 mm
00-8005-546-26

  • Polyethylene acetabulum prosthesis

ZCA® - 00889024638600

No Description
Zimmer, Inc.
8005-546-22
In Commercial Distribution

  • 00889024638600 ()

  • O.D. Cup With Spacers 49 mm
  • Lumen/Inner Diameter: 22.00 Millimeter
00-8005-546-22

  • Polyethylene acetabulum prosthesis

ZCA® - 00889024638594

No Description
Zimmer, Inc.
8005-544-28
In Commercial Distribution

  • 00889024638594 ()

  • Lumen/Inner Diameter: 28.00 Millimeter
  • O.D. Cup With Spacers 47 mm
00-8005-544-28

  • Polyethylene acetabulum prosthesis

ZCA® - 00889024638587

No Description
Zimmer, Inc.
8005-544-26
In Commercial Distribution

  • 00889024638587 ()

  • O.D. Cup With Spacers 47 mm
  • Lumen/Inner Diameter: 26.00 Millimeter
00-8005-544-26

  • Polyethylene acetabulum prosthesis

ZCA® - 00889024638570

No Description
Zimmer, Inc.
8005-544-22
In Commercial Distribution

  • 00889024638570 ()

  • Lumen/Inner Diameter: 22.00 Millimeter
  • O.D. Cup With Spacers 47 mm
00-8005-544-22

  • Polyethylene acetabulum prosthesis

ZCA® - 00889024638563

No Description
Zimmer, Inc.
8005-542-26
In Commercial Distribution

  • 00889024638563 ()

  • O.D. Cup With Spacers 45 mm
  • Lumen/Inner Diameter: 26.00 Millimeter
00-8005-542-26

  • Polyethylene acetabulum prosthesis

ZCA® - 00889024638556

No Description
Zimmer, Inc.
8005-542-22
In Commercial Distribution

  • 00889024638556 ()

  • O.D. Cup With Spacers 45 mm
  • Lumen/Inner Diameter: 22.00 Millimeter
00-8005-542-22

  • Polyethylene acetabulum prosthesis

ZCA® - 00889024638549

No Description
Zimmer, Inc.
8005-540-22
In Commercial Distribution

  • 00889024638549 ()

  • O.D. Cup With Spacers 43 mm
  • Lumen/Inner Diameter: 22.00 Millimeter
00-8005-540-22

  • Polyethylene acetabulum prosthesis

GSO ACP1 Spinal System - M9935097310

Palm Handle with AO Quick Connect
UNIFIED SPINE, LLC
509731
In Commercial Distribution

  • M9935097310 ()

  • Palm Handle with AO Quick Connect


  • Surgical instrument handle, torque-limiting

OxyMask™ - 10620974001369

OxyMulti Kid Ultra Kit with Nebulizer
Southmedic Incorporated
OKMK-4025-8
Not in Commercial Distribution

  • 10620974001369 ()
  • 00620974001362 ()

  • OxyMulti Kid Ultra Kit with Nebulizer
OKMK-4025-8

  • Vortex oxygen face mask

OxyMulti-Mask™ - 10620974000607

OxyPlus High Humidity Kit with Nebulizer
Southmedic Incorporated
OPMK-4025-8
In Commercial Distribution

  • 10620974000607 ()
  • 00620974000600 ()

  • OxyPlus High Humidity Kit with Nebulizer
OPMK-4025-8

  • Vortex oxygen face mask

OxyMulti-Mask™ - 10620974000560

OxyMulti Mask High Humidity with nebulizer
Southmedic Incorporated
OMMK-4025-8
In Commercial Distribution

  • 10620974000560 ()
  • 00620974000563 ()

  • OxyMulti Mask High Humidity with nebulizer
OMMK-4025-8

  • Vortex oxygen face mask

OxyMask™ - 10620974000287

OxyMask CO2 with oxygen Tubing 14ft
Southmedic Incorporated
OM-2125-14
In Commercial Distribution

  • 10620974000287 ()
  • 00620974000280 ()

  • OxyMask CO2 with oxygen Tubing 14ft
OM-2125-14

  • Breathing circuit gas-sampling/monitoring set

NexGen® - 00889024263727

No Description
Zimmer, Inc.
90-5970-50-20
In Commercial Distribution

  • 00889024263727 ()

  • Size Blue / C-H, With Locking Screw
  • Height: 20 Millimeter
90-5970-050-20

  • Tibial insert

NexGen® - 00889024263710

No Description
Zimmer, Inc.
90-5970-50-17
In Commercial Distribution

  • 00889024263710 ()

  • Size Blue / C-H, With Locking Screw
  • Height: 17 Millimeter
90-5970-050-17

  • Tibial insert

Rospital Productos Medicos - 00812460024591

ENDOTRACHEAL TUBE WITH CUFF, 5.5MM. EACH
ATLAS MEDICAL PRODUCTS LLC
AMPET55
In Commercial Distribution

  • 10812460024598 ()
  • 00812460024591 ()
  • 20812460024595 ()

  • ENDOTRACHEAL TUBE WITH CUFF, 5.5MM. EACH
AMPET55

  • Basic endotracheal tube, single-use

Rospital Productos Medicos - 00812460024577

ENDOTRACHEAL TUBE WITH CUFF, 9.0MM EACH.
ATLAS MEDICAL PRODUCTS LLC
AMPET90
In Commercial Distribution

  • 10812460024574 ()
  • 00812460024577 ()
  • 20812460024571 ()

  • ENDOTRACHEAL TUBE WITH CUFF, 9.0MM EACH.
AMPET90

  • Basic endotracheal tube, single-use

Rospital Productos Medicos - 00812460024560

ENDOTRACHEAL TUBE WITH CUFF, 8.5MM. EACH.
ATLAS MEDICAL PRODUCTS LLC
AMPET85
In Commercial Distribution

  • 10812460024567 ()
  • 00812460024560 ()
  • 20812460024564 ()

  • ENDOTRACHEAL TUBE WITH CUFF, 8.5MM. EACH.
AMPET85

  • Basic endotracheal tube, single-use

CAREFLOW(TM) 1 LUMEN 5FR X 150MM - 00886333616602

Kits Contents : Catheter with Floswitch 5FR OD 1.75mmx150mm; J guidewire OD 0.9mmx450mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Floswitch(TM) Overneedle Introducer 15G OD 1.7mmx70mm, Dilator 8FR OD 2.69mm ID 0.96mm.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
681660
In Commercial Distribution

  • 50886333616607 ()
  • 00886333616602 ()

  • Catheter with Floswitch 5FR OD 1.75mmx150mm
681660

  • Vascular catheter introduction set, nonimplantable

CRITICATH SP5107-13 TD CATHETER - 00886333603541

Catheter with 7FR, 4Lumen, length 110cm
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
680354
In Commercial Distribution

  • 50886333603546 ()
  • 00886333603541 ()

  • Catheter with 7FR, 4Lumen, length 110cm
680354

  • Pulmonary artery balloon catheter, electrical

CRITICATH(TM) SP5107H-14 TD CATHETER - 00886333600526

Heparin coated Catheter 7FR, 4Lumen with length 110cm
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
680052
In Commercial Distribution

  • 50886333600521 ()
  • 00886333600526 ()

  • Catheter 7FR, 4Lumen with length 110cm
680052

  • Pulmonary artery balloon catheter, electrical

CRITICATH(TM) SP5107H-13 TD CATHETER - 00886333600519

Heaprin coated catheter 7FR, 4Lumen with length 110cm
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
680051
In Commercial Distribution

  • 50886333600514 ()
  • 00886333600519 ()

  • catheter 7FR, 4Lumen with length 110cm
680051

  • Pulmonary artery balloon catheter, electrical

CRITIKIT(TM) SP4572 - 00886333600021

Injectate delivery system includes a sensor housing with two-way check valve, a cooling coil, a IV administration set, a 10 cc control syringe, 3-way stopcock and two male luer lock protective covers.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
680002
In Commercial Distribution

  • 50886333600026 ()
  • 00886333600021 ()

  • Coo;ing Coil with 5.5 coils
680002

  • Thermal-dilution cardiac output unit

2W-AD60 - 00886333621149

2-Way Adset 60" tube length
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682114
In Commercial Distribution

  • 50886333621144 ()
  • 00886333621149 ()

  • 2-Way Adset with 60" tubing length
682114

  • Invasive blood pressure monitoring tubing set

MEDENTiKA - EMKAH14109

Scanbody
MEDENTiKA GmbH
H 1410
In Commercial Distribution

  • 04251574816726 ()
  • EMKAH14109 ()

  • compatible with BIOMET 3i / Certain®*
H 1410

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAH14009

Scanbody
MEDENTiKA GmbH
H 1400
In Commercial Distribution

  • 04251574816719 ()
  • EMKAH14009 ()

  • compatible with BIOMET 3i / Certain®*
H 1400

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAB91009

MedentiCAD wax-up base
MEDENTiKA GmbH
B 9100
In Commercial Distribution

  • 04251574806338 ()
  • EMKAB91009 ()

  • compatible with Bredent Medical / SKY®*
B 9100

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAB80T9

Placement instrument laboratory implant
MEDENTiKA GmbH
B 80 T
In Commercial Distribution

  • 04251574806277 ()
  • EMKAB80T9 ()

  • compatible with Bredent Medical / SKY®*
B 80 T

  • Dental implant analog

MEDENTiKA - EMKAB809

Laboratory implant
MEDENTiKA GmbH
B 80
In Commercial Distribution

  • 04251574834263 ()
  • EMKAB809 ()

  • compatible with Bredent Medical / SKY®*
B 80

  • Dental implant analog

MEDENTiKA - EMKAB60SB9

Scanbody retention screw
MEDENTiKA GmbH
B 60 SB
In Commercial Distribution

  • 04251574806246 ()
  • EMKAB60SB9 ()

  • compatible with Bredent Medical / SKY®*
B 60 SB

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - EMKAB60LET9

Laboratory screw
MEDENTiKA GmbH
B 60 L-ET
In Commercial Distribution

  • 04251574837592 ()
  • EMKAB60LET9 ()

  • compatible with Bredent Medical / SKY®*
B 60 L-ET

  • Dental prosthesis/implant abutment screw analog, reusable

MEDENTiKA - EMKAB60L9

Laboratory screw
MEDENTiKA GmbH
B 60 L
In Commercial Distribution

  • 04251574806239 ()
  • EMKAB60L9 ()

  • compatible with Bredent Medical / SKY®*
B 60 L

  • Dental prosthesis/implant abutment screw analog, reusable

MEDENTiKA - EMKAB509

Laboratory implant
MEDENTiKA GmbH
B 50
In Commercial Distribution

  • 04251574806215 ()
  • EMKAB509 ()

  • compatible with Bredent Medical / SKY®*
B 50

  • Dental implant analog

MEDENTiKA - EMKAB49009

MedentiBASE Scanbody
MEDENTiKA GmbH
B 4900
In Commercial Distribution

  • 04251574806208 ()
  • EMKAB49009 ()

  • compatible with Bredent Medical / SKY®*
B 4900

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAB46209

MedentiBASE implant pick-up
MEDENTiKA GmbH
B 4620
In Commercial Distribution

  • 04251574806116 ()
  • EMKAB46209 ()

  • compatible with Bredent Medical / SKY®*
B 4620

  • Dental implant suprastructure, temporary, preformed, reusable
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