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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 - EMKAI40RT9

Guide sleeve
MEDENTiKA GmbH
I 40 RT
In Commercial Distribution

  • 04251574844170 ()
  • EMKAI40RT9 ()

  • compatible with BIOMET 3i / External Hex
I 40 RT

  • Surgical drill guide, single-use

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

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

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 - 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 - 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

A.L.P.S.SCHANZ PIN - 00887868076695

No Description
Biomet Orthopedics, LLC
110008327
In Commercial Distribution

  • 00887868076695 ()

  • 5MM X 50MM WITH A/O
110008327

  • Orthopaedic bone wire

A.L.P.S.® - 00887868457852

No Description
Biomet Orthopedics, LLC
110008327
In Commercial Distribution

  • 00887868457852 ()

  • 5 MM X 50 MM With
110008327

  • Orthopaedic bone wire

CLC1600 Chemistry Analyzer with ISE Module - 00817302023114

CLC1600 Clinical Chemistry Anallyzer with ISE
CAROLINA LIQUID CHEMISTRIES CORPORATION
CLC1600
In Commercial Distribution

  • 00817302023114 ()

  • Depth: 35 Inch
  • Height: 44 Inch
  • Width: 50 Inch
  • CLC1600 Clinical Chemistry Anallyzer with ISE
CLC1600i

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

CLC800 Chemistry Analyzer with ISE Module - 00817302023107

CLC800 Clinical Chemistry Anallyzer with ISE
CAROLINA LIQUID CHEMISTRIES CORPORATION
CLC800
In Commercial Distribution

  • 00817302023107 ()

  • Width: 42 Inch
  • CLC800 Clinical Chemistry Analyzer with ISE
  • Height: 45 Inch
  • Depth: 31 Inch
CLC800i

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

NA - 00889024066014

No Description
Zimmer, Inc.
3121
In Commercial Distribution

  • 00889024066014 ()

  • 9-5/8 Inch (245mm) With Ratchet
00-3121-000-00

  • Orthopaedic prosthesis implantation positioning instrument, reusable

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

Continuous Single Culture® Complete with Gentamicin Sulfate with Human Serum Alb - 00857515006412

Continuous Single Culture® Complete with HSA
FUJIFILM IRVINE SCIENTIFIC, INC.
90165-60mL
In Commercial Distribution

  • 00857515006412 ()

  • Total Volume: 60 Milliliter
90165

  • IVF medium

Dual Swivel Elbow with Suction Port, 6" Expandable Tubing with 22F Connector - 00858409005573

No Description
Medicomp
MC-7480
Not in Commercial Distribution

  • 10858409005570 ()
  • 00858409005573 ()
MC-7480

  • Straight/elbow breathing circuit connector, single-use

Dual Swivel Elbow with Suction Port, 6" Expandable Tubing with 22F Connector - 00858409005481

No Description
Medicomp
MC-5480
Not in Commercial Distribution

  • 10858409005488 ()
  • 00858409005481 ()
MC-5480

  • Straight/elbow breathing circuit connector, single-use

Dual Swivel Elbow with Suction Port, 6" Expandable Tubing with 15M Connector - 00858409005566

No Description
Medicomp
MC-7475
Not in Commercial Distribution

  • 10858409005563 ()
  • 00858409005566 ()
MC-7475

  • Straight/elbow breathing circuit connector, single-use

Adult Expandable Circuit 96" Y-Piece with Luer Elbow Bacterial Viral Filter with - 05055788747819

No Description
FLEXICARE MEDICAL LIMITED
038-01-616U
In Commercial Distribution

  • 05055788747819 ()


  • Anaesthesia breathing circuit, single-use

Fenwal Blood Comp. Recipient Set with Std. Blood Filter with Luer Adapter - 04052682004148

Blood Component Recipient Set with Standard Blood Filter with Luer Adapter. Sterile Fluid Path
Fresenius Kabi AG
4C2160
In Commercial Distribution

  • 14052682004145 ()
  • 04052682004148 ()
4C2160

  • Blood transfusion set, non-exchange

Continuous Single Culture® Complete with Gentamicin Sulfate with Human Serum Alb - 00893727002651

Continuous Single Culture® Complete with HSA
FUJIFILM IRVINE SCIENTIFIC, INC.
90165-2x20mL
In Commercial Distribution

  • 00893727002651 ()
  • 10893727002658 ()

  • Total Volume: 20 Milliliter
90165

  • IVF medium

Steel Guidewire with PTFE Ø0.035”,L. 150cm,standard,with 3cm straight flexible - 03700512966173

No Description
Promepla
09-0013
In Commercial Distribution

  • 03700512986171 ()
  • 03700512966173 ()
  • 03700512976172 ()
ROWG3500ST

  • Ureteral catheter

TURP Irrigation set with flushing system for laser vaporization – Use with Gravi - 03700512900962

No Description
Promepla
ONGE2001ST12
In Commercial Distribution

  • 03700512920960 ()
  • 03700512910961 ()
  • 03700512900962 ()
ONGE2001ST12

  • Surgical irrigation/aspiration tubing set

A-SERIES MOBILE FLOORSTAND BASE WITHOUT COLUMN, WITH DROP-IN WEIGHTS, USE WITH M - 00810040250712

No Description
GLOBAL SURGICAL CORPORATION
M A730FB
In Commercial Distribution

  • 00810040250712 ()


  • General-purpose surgical microscope

Ventury Dry - 00860007020926

Accessory connector to be used with Venturi MicroDry, compatible with Olympus endoscope
GI Scientific LLC
Universal Connector with Auxiliary Jet Connector Olympus
In Commercial Distribution

  • 00860007020926 ()
VDU-06-00023

  • Surgical instrument/endoscope cleaning utensil, reusable

microTargeting™ Insertion Tube - 00873263003992

microTargeting Lead Insertion Tube with stylet, Sterile, for use with Stereotactic System
FHC, INC.
66-IT-1019-00399
In Commercial Distribution

  • 10873263003999 ()
  • 00873263003992 ()

  • Outer Diameter: 1.83 Millimeter
  • Length: 239.9 Millimeter
  • Lumen/Inner Diameter: 1.6 Millimeter
66-IT-1019

  • Intracerebral cannula, implantable

microTargeting Insertion Tube - 00873263003497

microTargeting Lead Insertion Tube with Stylet, Sterile, for use with microTargeting Platform
FHC, INC.
66-IT-AR4P-00349
In Commercial Distribution

  • 10873263003494 ()
  • 00873263003497 ()

  • Length: 188 Millimeter
  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.83 Millimeter
66-IT-AR4P

  • Intracerebral cannula, implantable

microTargeting™ Insertion Tube - 00873263003428

microTargeting Lead Insertion Tube with Stylet, Sterile, for use with Stereotactic Frame
FHC, INC.
66-IT-AR6P-00342
In Commercial Distribution

  • 10873263003425 ()
  • 00873263003428 ()

  • Length: 229.85 Millimeter
  • Outer Diameter: 1.83 Millimeter
  • Lumen/Inner Diameter: 1.6 Millimeter
66-IT-AR6P

  • Intracerebral cannula, implantable

microTargeting™ Insertion Tube - 00873263003329

microTargeting Single Insertion Tube with Stylet, Sterile, for use with Stereotactic Frame
FHC, INC.
66-IT-BP8P-00332
In Commercial Distribution

  • 10873263003326 ()
  • 00873263003329 ()

  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.83 Millimeter
  • Length: 219 Millimeter
66-IT-BP8P

  • Intracerebral cannula, implantable

DELFIA Wash Concentrate - 06438147149865

For use with the DELFIA® Platewash after dilution with deionized water.
Wallac Oy
4010-0010
In Commercial Distribution

  • 06438147149865 ()
4010-0010

  • Buffered wash solution IVD

Batrik Bitestrong Bite Blocks - 00690521000148

Bitestrong Bite Blocks with Nasal Oxygen Delivery, 18 mm, Reusable, with strap
Batrik Medical Manufacturing Inc
BO2-R
In Commercial Distribution

  • 00690521000148 ()
BO2-R

  • Endoscopic bite block, basic, single-use

Orantech - 06941691968207

With inflation bag, Single tube, With connector Large Adult Long Range 33-47cm
Orantech Inc.
M-BP-80BS
In Commercial Distribution

  • 06941691968207 ()


  • Blood pressure cuff, reusable

Orantech - 06941691954927

With inflation bag, Single tube, With connector Adult Extra Long Range 23-46cm
Orantech Inc.
BP-60BS-W37
In Commercial Distribution

  • 06941691954927 ()


  • Blood pressure cuff, reusable

Y-Tube - 14048223016029

Y-Tube Injection tube with "Y"-connector to be used with two InfiltraLong
Pajunk GmbH Medizintechnologie
001151-37W
Not in Commercial Distribution

  • 14048223016029 ()
  • 04048223016022 ()
001151-37W

  • Catheter injection port

TL - 14048223014056

TL 22G x 100mm, Tip 5mm, with crocodile clamp and tube with
Pajunk GmbH Medizintechnologie
001155-22
Not in Commercial Distribution

  • 14048223014056 ()
  • 04048223014059 ()
001155-22

  • Percutaneous radio-frequency ablation probe cannula, single-use

TL - 14048223014032

TL 22G x 60mm, Tip 5mm, with crocodile clamp and tube with
Pajunk GmbH Medizintechnologie
001155-12
Not in Commercial Distribution

  • 14048223014032 ()
  • 04048223014035 ()
001155-12

  • Percutaneous radio-frequency ablation probe cannula, single-use

Orantech - 06941691981367

With inflation bag, Double tube, With connector Adult Extra Long Range 23-46cm
Orantech Inc.
BP-60BD-WD01M
In Commercial Distribution

  • 06941691981367 ()


  • Blood pressure cuff, reusable

Orantech - 06941691980728

Coffee PU, With bag, With connector Double tube Large Adult Range 33-47cm
Orantech Inc.
BPN-70BD-W38
In Commercial Distribution

  • 06941691980728 ()


  • Blood pressure cuff, reusable

HexaLux - 00724995172473

The HexaLux Mobile Stand with Batteries is used with the HexaLux Light.
STERIS
HexaLux Light Mobile Stand
Not in Commercial Distribution

  • 00724995172473 ()
EXLMWBHUS

  • Fixed examination/treatment room light

Orantech - 06941691968580

With inflation bag, Single tube, With connector Adult Extra Long Range 23-46cm
Orantech Inc.
BP-60BS-W44
In Commercial Distribution

  • 06941691968580 ()


  • Blood pressure cuff, reusable

Orantech - 06941691961888

With inflation bag, Single tube, With connector Adult Extra Long Range 23-46cm
Orantech Inc.
BP-60BS-W44
In Commercial Distribution

  • 06941691961888 ()


  • Blood pressure cuff, reusable

Orantech - 06941691954941

With inflation bag, Single tube, With connector Large Adult Long Range 31-53cm
Orantech Inc.
BP-80BS-W37
In Commercial Distribution

  • 06941691954941 ()


  • Blood pressure cuff, reusable

Health o meter professional - 00851628008318

Digital platform scale with handrails and height rod, kg only with bt
Pelstar, LLC
2101KGHR-BT
In Commercial Distribution

  • 00851628008318 ()


  • Stand-on floor scale, electronic

Health o meter Professional - 00851628008264

Digital Platform Scale with Handrails and Height Rod, KG only with Bluetooth
Pelstar, LLC
1100KGHR-BT
In Commercial Distribution

  • 00851628008264 ()


  • Stand-on floor scale, electronic

CopperUnder sock Extra Large - 00850051939541

A sock made with 40% MODAACRYLIC infused with copper polyester Extra Large
SUN SCIENTIFIC, INC.
AW7025-02
In Commercial Distribution

  • 00850051939541 ()
CS400

  • Compression/pressure sock/stocking, reusable

CopperUnder sock Small/Medium - 00850051939527

A sock made with 40% MODAACRYLIC infused with copper polyester small/medium
SUN SCIENTIFIC, INC.
AW7025-00
In Commercial Distribution

  • 00850051939527 ()
CS150

  • Compression/pressure sock/stocking, reusable

Orantech - 06941691974147

With inflation bag, Double tube, With connector Small Adult, Adult, Large Adult
Orantech Inc.
BP-4570BD-W38
In Commercial Distribution

  • 06941691974147 ()


  • Blood pressure cuff, reusable

NA - 00845384002413

7 mm Fluted Ball. Use with B-GREY-MIA20 Attachment. Use with B-GREY-MIA20 Attachment.
Anspach Effort, The
GREY-MIA20-7
Not in Commercial Distribution

  • 00845384002413 ()
GREY-MIA20-7

  • Cranial bur, single-use
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