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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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CORE DYNAMICS - 20653405044779

15mm x 60mm Thoracoscopy Cannula With Blunt Tip Trocar, Reusable
Conmed Corporation
CD1415
Not in Commercial Distribution

  • 30653405044776 ()
  • 20653405044779 ()

  • Thoracoscopy Cannula With Blunt Trocar Tip
CD1415

  • Laparoscopic surgical procedure kit, non-medicated, reusable

CORE DYNAMICS - 20653405044762

10/12mm x 60mm Thoracoscopy Cannula With Blunt Tip Trocar, Reusable
Conmed Corporation
CD1412
Not in Commercial Distribution

  • 30653405044769 ()
  • 20653405044762 ()

  • Thoracoscopy Cannula With Blunt Trocar Tip
CD1412

  • Laparoscopic surgical procedure kit, non-medicated, reusable

CORE DYNAMICS - 20653405044755

10/11 mm x 60mm Thoracoscopy Cannula With Blunt Tip Trocar, Reusable
Conmed Corporation
CD1411
Not in Commercial Distribution

  • 30653405044752 ()
  • 20653405044755 ()

  • Thoracoscopy Cannula With Blunt Trocar Tip
CD1411

  • Laparoscopic surgical procedure kit, non-medicated, reusable

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

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

MEDENTiKA - EMKAE699

Abutment Screw
MEDENTiKA GmbH
E 69
In Commercial Distribution

  • 04251574835260 ()
  • EMKAE699 ()

  • compatible with Nobel Biocare Replace Select
E 69

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - EMKAE689

Abutment Screw
MEDENTiKA GmbH
E 68
In Commercial Distribution

  • 04251574835253 ()
  • EMKAE689 ()

  • compatible with Nobel Biocare Replace Select
E 68

  • Dental implant suprastructure, permanent, preformed

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 - EMKAB509

Laboratory implant
MEDENTiKA GmbH
B 50
In Commercial Distribution

  • 04251574806215 ()
  • EMKAB509 ()

  • compatible with Bredent Medical / SKY®*
B 50

  • Dental implant analog

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

MEDENTiKA - EMKAB40RK9

Drilling sleeve
MEDENTiKA GmbH
B 40 RK
In Commercial Distribution

  • 04251574833723 ()
  • EMKAB40RK9 ()

  • compatible with Bredent Medical / SKY®*
B 40 RK

  • Surgical drill guide, single-use

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 - 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 - EMKAB40RT9

Guide sleeve
MEDENTiKA GmbH
B 40 RT
In Commercial Distribution

  • 04251574841544 ()
  • EMKAB40RT9 ()

  • compatible with Bredent Medical / SKY®*
B 40 RT

  • Surgical drill guide, single-use

MEDENTiKA - EMKAB14009

Scanbody
MEDENTiKA GmbH
B 1400
In Commercial Distribution

  • 04251574805928 ()
  • EMKAB14009 ()

  • compatible with Bredent Medical / SKY®*
B 1400

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAI14109

Scanbody
MEDENTiKA GmbH
I 1410
In Commercial Distribution

  • 04251574818447 ()
  • EMKAI14109 ()

  • compatible with BIOMET 3i / External Hex
I 1410

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAI14009

Scanbody
MEDENTiKA GmbH
I 1400
In Commercial Distribution

  • 04251574818430 ()
  • EMKAI14009 ()

  • compatible with BIOMET 3i / External Hex
I 1400

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAH91209

MedentiCAD wax-up base
MEDENTiKA GmbH
H 9120
In Commercial Distribution

  • 04251574818171 ()
  • EMKAH91209 ()

  • compatible with BIOMET 3i / Certain®*
H 9120

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAH91109

MedentiCAD wax-up base
MEDENTiKA GmbH
H 9110
In Commercial Distribution

  • 04251574818164 ()
  • EMKAH91109 ()

  • compatible with BIOMET 3i / Certain®*
H 9110

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAH91009

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

  • 04251574818157 ()
  • EMKAH91009 ()

  • compatible with BIOMET 3i / Certain®*
H 9100

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAH85139

Multi-unit scanbody
MEDENTiKA GmbH
H 8513
In Commercial Distribution

  • 04251574818027 ()
  • EMKAH85139 ()

  • compatible with BIOMET 3i / Certain®*
H 8513

  • Dental implant suprastructure, temporary, preformed, single-use

MEDENTiKA - EMKAH85089

Multi-unit titanium base
MEDENTiKA GmbH
H 8508
In Commercial Distribution

  • 04251574818010 ()
  • EMKAH85089 ()

  • compatible with BIOMET 3i / Certain®*
H 8508

  • Dental implant suprastructure, permanent, preformed
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