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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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MEDENTiKA - EMKAH80009

Multi-unit Abutment
MEDENTiKA GmbH
H 8000
In Commercial Distribution

  • 04251574843968 ()
  • EMKAH80009 ()

  • compatible with BIOMET 3i / Certain®*
H 8000

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - EMKAH76009

MedentiBASE bridge screw
MEDENTiKA GmbH
H 7600
In Commercial Distribution

  • 04251574817846 ()
  • EMKAH76009 ()

  • compatible with BIOMET 3i / Certain®*;
H 7600

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - EMKAH639

Abutment Screw
MEDENTiKA GmbH
H 63
In Commercial Distribution

  • 04251574835291 ()
  • EMKAH639 ()

  • compatible with Nobel Biocare Nobel Active
H 64

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - EMKAH60SB9

Scanbody retention screw
MEDENTiKA GmbH
H 60 SB
In Commercial Distribution

  • 04251574817655 ()
  • EMKAH60SB9 ()

  • compatible with BIOMET 3i / Certain®*
H 60 SB

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - EMKAH60LET9

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

  • 04251574837707 ()
  • EMKAH60LET9 ()

  • compatible with BIOMET 3i / Certain®*
H 60 L-ET

  • Dental prosthesis/implant abutment screw analog, reusable

MEDENTiKA - EMKAH60L9

Laboratory screw
MEDENTiKA GmbH
H 60 L
In Commercial Distribution

  • 04251574817648 ()
  • EMKAH60L9 ()

  • compatible with BIOMET 3i / Certain®*
H 60 L

  • Dental prosthesis/implant abutment screw analog, reusable

MEDENTiKA - EMKAH609

Abutment screw
MEDENTiKA GmbH
H 60
In Commercial Distribution

  • 04251574817631 ()
  • EMKAH609 ()

  • compatible with BIOMET 3i / Certain®*;
H 60

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - EMKAH529

Laboratory implant
MEDENTiKA GmbH
H 52
In Commercial Distribution

  • 04251574817549 ()
  • EMKAH529 ()

  • compatible with BIOMET 3i / Certain®*
H 52

  • Dental implant analog

MEDENTiKA - EMKAH519

Laboratory implant
MEDENTiKA GmbH
H 51
In Commercial Distribution

  • 04251574817495 ()
  • EMKAH519 ()

  • compatible with BIOMET 3i / Certain®*
H 51

  • Dental implant analog

MEDENTiKA - EMKAH509

Laboratory implant
MEDENTiKA GmbH
H 50
In Commercial Distribution

  • 04251574817440 ()
  • EMKAH509 ()

  • compatible with BIOMET 3i / Certain®*
H 50

  • Dental implant analog

MEDENTiKA - EMKAH49009

MedentiBASE Scanbody
MEDENTiKA GmbH
H 4900
In Commercial Distribution

  • 04251574817433 ()
  • EMKAH49009 ()

  • compatible with BIOMET 3i / Certain®*
H 4900

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAH48409

MedentiBASE titanium base incl. Screw
MEDENTiKA GmbH
H 4840
In Commercial Distribution

  • 04251574817426 ()
  • EMKAH48409 ()

  • compatible with BIOMET 3i / Certain®*;
H 4840

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - EMKAH48209

MedentiBASE adhesive cap incl. Screw
MEDENTiKA GmbH
H 4820
In Commercial Distribution

  • 04251574817402 ()
  • EMKAH48209 ()

  • compatible with BIOMET 3i / Certain®*;
H 4820

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - EMKAH48009

MedentiBASE adhesive cap incl. Screw
MEDENTiKA GmbH
H 4800
In Commercial Distribution

  • 04251574817389 ()
  • EMKAH48009 ()

  • compatible with BIOMET 3i / Certain®*;
H 4800

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - EMKAH47209

MedentiBASE gold cap, castable incl. Screw
MEDENTiKA GmbH
H 4720
In Commercial Distribution

  • 04251574817372 ()
  • EMKAH47209 ()

  • compatible with BIOMET 3i / Certain®*;
H 4720

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - EMKAH47009

MedentiBASE titanium cap incl. Screw
MEDENTiKA GmbH
H 4700
In Commercial Distribution

  • 04251574817358 ()
  • EMKAH47009 ()

  • compatible with BIOMET 3i / Certain®*;
H 4700

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - EMKAH46209

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

  • 04251574817341 ()
  • EMKAH46209 ()

  • compatible with BIOMET 3i / Certain®*
H 4620

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAH46109

MedentiBASE cover cap
MEDENTiKA GmbH
H 4610
In Commercial Distribution

  • 04251574817334 ()
  • EMKAH46109 ()

  • compatible with BIOMET 3i / Certain®*;
H 4610

  • Dental implant suprastructure, permanent, preformed

MEDENTiKA - EMKAH41RT9

Guide sleeve
MEDENTiKA GmbH
H 41 RT
In Commercial Distribution

  • 04251574843951 ()
  • EMKAH41RT9 ()

  • compatible with BIOMET 3i / Certain®*
H 41 RT

  • Surgical drill guide, single-use

MEDENTiKA - EMKAH41RK9

Drilling sleeve
MEDENTiKA GmbH
H 41 RK
In Commercial Distribution

  • 04251574833945 ()
  • EMKAH41RK9 ()

  • compatible with BIOMET 3i / Certain®*
H 41 RK

  • Surgical drill guide, single-use

MEDENTiKA - EMKAH40RT9

Guide sleeve
MEDENTiKA GmbH
H 40 RT
In Commercial Distribution

  • 04251574843944 ()
  • EMKAH40RT9 ()

  • compatible with BIOMET 3i / Certain®*
H 40 RT

  • Surgical drill guide, single-use

MEDENTiKA - EMKAH40RK9

Drilling sleeve
MEDENTiKA GmbH
H 40 RK
In Commercial Distribution

  • 04251574833938 ()
  • EMKAH40RK9 ()

  • compatible with BIOMET 3i / Certain®*
H 40 RK

  • Surgical drill guide, single-use

MEDENTiKA - EMKAH329

Implant pick-up
MEDENTiKA GmbH
H 32
In Commercial Distribution

  • 04251574817099 ()
  • EMKAH329 ()

  • compatible with BIOMET 3i / Certain®*
H 32

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAH319

Implant pick-up
MEDENTiKA GmbH
H 31
In Commercial Distribution

  • 04251574817068 ()
  • EMKAH319 ()

  • compatible with BIOMET 3i / Certain®*
H 31

  • Dental implant suprastructure, temporary, preformed, reusable

MEDENTiKA - EMKAH309

Implant pick-up
MEDENTiKA GmbH
H 30
In Commercial Distribution

  • 04251574817037 ()
  • EMKAH309 ()

  • compatible with BIOMET 3i / Certain®*
H 30

  • Dental implant suprastructure, temporary, preformed, reusable

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 - 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 - 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

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 - 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 - EMKAB14009

Scanbody
MEDENTiKA GmbH
B 1400
In Commercial Distribution

  • 04251574805928 ()
  • EMKAB14009 ()

  • compatible with Bredent Medical / SKY®*
B 1400

  • Dental implant suprastructure, temporary, preformed, reusable

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

CLC6410 Chemistry Analyzer with or without ISE - 00817302023121

CLC6410 Clinical Chemistry Analyzer with ISE
CAROLINA LIQUID CHEMISTRIES CORPORATION
CLC6410
In Commercial Distribution

  • 00817302023121 ()

  • Height: 46 Inch
  • Width: 76 Inch
  • Depth: 49 Inch
  • CLC6410 Clinical Chemistry Analyzer with ISE
CLC6410i

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
  • Multi-modality clinical specimen analysis system IVD

COMFYCOMBPLUS - 00816924020242

DIGITAL TENS/MUSCLE WITH 7 MODES AND 24 PRESETS
Tensproducts, LLC
COMFYCOMBOPLUS
In Commercial Distribution

  • 10816924020249 ()
  • 00816924020372 ()
  • 00816924020242 ()
  • 00816924020778 ()
  • 10816924020775 ()
  • 00816924020730 ()
COMFYCOMBOPLUS, COMFYCOMBOPLUS-JETT, COMFYCOMBOPLUS-TP,COMFYCOMBOPLUS-MFR

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

Duo Double Electric Breast Pump - 00887529000465

The Duo Double Electric Breast Pump is a single user, double electric breast pump that includes customizable massage and expression modes and is capable of single and double pumping.
Bistos Co., Ltd.
AAA0021
In Commercial Distribution

  • 00887529000465 ()
  • 00887529000472 ()
  • 10887529000479 ()
  • 00887529000489 ()
  • 10887529000486 ()


  • Breast pump, electric
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