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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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NA - 00724995000639

The Flow Units are accessories that facilitate use of the Reliance EPS processor with specific endoscopes and endoscope accessory parts.
Corporation Steris Canada
Flow Unit 7
In Commercial Distribution

  • 00724995000639 ()
EPSC007INT

  • Luminal device flushing tubing set, reusable

NA - 00724995194420

The Flow Units are accessories that facilitate use of the Reliance EPS processor with specific endoscopes and endoscope accessory parts.
Corporation Steris Canada
Flow Unit 11
Not in Commercial Distribution

  • 00724995194420 ()
EPSC011INT

  • Luminal device flushing tubing set, reusable

NA - 00724995087920

The Flow Units are accessories that facilitate use of the Reliance EPS processor with specific endoscopes and endoscope accessory parts.
Corporation Steris Canada
Flow Unit 5
Not in Commercial Distribution

  • 00724995087920 ()
EPSC005INT

  • Luminal device flushing tubing set, reusable

NA - 00724995002619

The Flow Units are accessories that facilitate use of the Reliance EPS processor with specific endoscopes and endoscope accessory parts.
Corporation Steris Canada
Flow Unit 10
Not in Commercial Distribution

  • 00724995002619 ()
EPSC010INT

  • Luminal device flushing tubing set, reusable

NA - 00724995001551

The Flow Units are accessories that facilitate use of the Reliance EPS processor with specific endoscopes and endoscope accessory parts.
Corporation Steris Canada
Flow Unit 9
Not in Commercial Distribution

  • 00724995001551 ()
EPSC009INT

  • Luminal device flushing tubing set, reusable

NA - 00724995001544

The Flow Units are accessories that facilitate use of the Reliance EPS processor with specific endoscopes and endoscope accessory parts.
Corporation Steris Canada
Flow Unit 8
Not in Commercial Distribution

  • 00724995001544 ()
EPSC008INT

  • Luminal device flushing tubing set, reusable

PILLING - 24026704450163

4TH BLADE ATTACHMENT LEFT NO BLADE
TELEFLEX INCORPORATED
IPN003591
In Commercial Distribution

  • 24026704450163 ()
  • 04026704450169 ()

  • For left arm (blade not included)
  • Length: 9.25 Inch
  • Width: 9.313 Inch
165171

  • Surgical retractor/retraction system blade, reusable

PILLING - 24026704450156

4TH BLADE ATTACHMENT RIGHT NO BLADE
TELEFLEX INCORPORATED
IPN003590
In Commercial Distribution

  • 24026704450156 ()
  • 04026704450152 ()

  • Width: 9.313 Inch
  • Length: 9.25 Inch
  • For right arm (blade not included)
165170

  • Surgical retractor/retraction system blade, reusable

Paltop - 07290108694833

Final Depth Pin for 6.0 implant
PALTOP ADVANCED DENTAL SOLUTIONS LTD
60-70089
In Commercial Distribution

  • 07290108694833 ()

  • Final Depth Pin for 6.0 implant
60-70089

  • Dental implantation depth/angle gauge, reusable

Paltop - 07290108692006

Final Depth Pin for Ø5mm Implant
PALTOP ADVANCED DENTAL SOLUTIONS LTD
60-70088
In Commercial Distribution

  • 07290108692006 ()

  • Final Depth Pin for 5.0 implant
60-70088

  • Dental implantation depth/angle gauge, reusable

Paltop - 07290108691993

Final Depth Pin for Ø4.2mm Implant
PALTOP ADVANCED DENTAL SOLUTIONS LTD
60-70087
In Commercial Distribution

  • 07290108691993 ()

  • Final Depth Pin for 4.2 implant
60-70087

  • Dental implantation depth/angle gauge, reusable

Paltop - 07290108691986

Final Depth Pin for Ø3.75mm Implant
PALTOP ADVANCED DENTAL SOLUTIONS LTD
60-70086
In Commercial Distribution

  • 07290108691986 ()

  • Final Depth Pin for 3.75 implant
60-70086

  • Dental implantation depth/angle gauge, reusable

Paltop - 07290108691979

Final Depth Pin for Ø3.25mm Implant
PALTOP ADVANCED DENTAL SOLUTIONS LTD
60-70085
In Commercial Distribution

  • 07290108691979 ()

  • Final Depth Pin for 3.25 implant
60-70085

  • Dental implantation depth/angle gauge, reusable

OSSIO® Staple Sizing Guide - 07290019361046

OSSIO® Staple Sizing Guide.
OSSIO LTD
THN00292
In Commercial Distribution

  • 07290019361046 ()

  • For 15, 20, 25 mm Staples
THN00292

  • Surgical implant template, reusable

OSSIO® Drill Bit & Drill Guide Pack - 07290017630953

OSSIO® Drill Bit & Drill Guide Pack, For 5.5 mm Suture Anchor. Package contains: 1 Instrument Pack.
OSSIO LTD
THN00235
In Commercial Distribution

  • 07290017630953 ()

  • Instruments For 5.5 mm Suture Anchors
THN00235

  • Orthopaedic surgical procedure kit, non-medicated, single-use
  • Surgical drill guide, single-use
  • Fluted surgical drill bit, single-use

OSSIO® Drill Bit & Drill Guide Pack - 07290017630939

OSSIO® Drill Bit & Drill Guide Pack, For 4.75 mm Suture Anchor. Package contains: 1 Instrument Pack.
OSSIO LTD
THN00201
In Commercial Distribution

  • 07290017630939 ()

  • Instruments For 4.75 mm Suture Anchors
THN00201

  • Orthopaedic surgical procedure kit, non-medicated, single-use
  • Surgical drill guide, single-use
  • Fluted surgical drill bit, single-use

OSSIO® Compression Screw Instruments For 3.5 mm Screws - 07290017630915

OSSIO® Compression Screw Instruments For 3.5 mm Screws. Package contains: 1 Instrument Pack.
OSSIO LTD
THN00132
In Commercial Distribution

  • 07290017630915 ()

  • Instruments For 3.5 mm Diameter Screws
THN00132

  • Orthopaedic surgical procedure kit, non-medicated, single-use

OSSIO® Compression Screw Instruments For 4.0 mm Screws - 07290017630144

OSSIO® Compression Screw Instruments For 4.0 mm Screws. Package contains: 1 Instrument Pack.
OSSIO LTD
THN00057
In Commercial Distribution

  • 07290017630144 ()

  • Instruments For 4.0 mm Diameter Screws
THN00057

  • Orthopaedic surgical procedure kit, non-medicated, single-use

WalterLorenz™ Surgical Assist Arm - 00887868284366

No Description
BIOMET SPINE LLC
WAL80002
In Commercial Distribution

  • 00887868284366 ()

  • WALTER ADAPTOR FOR TSI SINGLE BLADE
WAL80002

  • General external orthopaedic fixation system implantation kit, reusable

n.a. - 04250105626155

Infusor 3000
VBM Medizintechnik GmbH
57-01-300
Not in Commercial Distribution

  • 04250105626155 ()

  • female Luer Lock ; for irrigation purposes
  • Total Volume: 3000 Milliliter


  • Intravenous pressure infusor, manual, reusable

HOLDING SLEEVE - 00192896083400

HOLDING SLEEVE
SONTEC INSTRUMENTS, INC.
1106-381
In Commercial Distribution

  • 00192896083400 ()

  • For 3.5 to 4 Millimeter Screws
1106-381

  • External orthopaedic fixation system, reusable

SCREW DRIVER SHAFT - 00192896083394

SCREW DRIVER SHAFT
SONTEC INSTRUMENTS, INC.
1106-284
In Commercial Distribution

  • 00192896083394 ()

  • For Tap Handle
  • 3.5 Millimeter Shaft
1106-284

  • Surgical screwdriver, reusable

PARALLEL DRILL GUIDE - 00192896082687

PARALLEL DRILL GUIDE CANNULATED SCREWS
SONTEC INSTRUMENTS, INC.
1103-1622
In Commercial Distribution

  • 00192896082687 ()

  • For 1.6 Millimeters
  • 4.5 Millimeter Screws
1103-1622

  • Surgical drill guide, reusable

LARGE PLATE/WIRE CUTTER - 00192896051454

LARGE PLATE/WIRE CUTTER
SONTEC INSTRUMENTS, INC.
1103-104
In Commercial Distribution

  • 00192896051454 ()

  • Length: 9.5 Inch
  • For wire up to 3.5 Millimeter
1103-104

  • Orthopaedic implantable-device cutter

WIRE END CUTTER - 00192896051416

WIRE END CUTTER DOUBLE ACTION TUNGSTEN CARBIDE BLADES
SONTEC INSTRUMENTS, INC.
1103-100
In Commercial Distribution

  • 00192896051416 ()

  • For wire up to 2.5 Millimeter
  • Length: 8.5 Inch
1103-100

  • Orthopaedic implantable-device cutter

MedibinoNEO ring – TG PUR Gel - Size S - PU6 - 04260764840571

Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840724 ()
  • 04260764840571 ()

  • Fits for premature infants weighting 200-800g
24021703-S

  • Infant recumbent sleep positioner

m-protect3 - 04262358420046

m-protect®3 is intended exclusively for use as an insertion guide of circular stapler instruments used for transanal stapled anastomosis.
qtec CE-med GmbH
33/34
In Commercial Distribution

  • 04262358420077 ()
  • 04262358420046 ()
  • 04262358420138 ()

  • suitable for stapler size 33/34
MP0033/34

  • Endoscopic-access dilator, single-use

m-protect3 - 04262358420039

m-protect®3 is intended exclusively for use as an insertion guide of circular stapler instruments used for transanal stapled anastomosis.
qtec CE-med GmbH
31/32
In Commercial Distribution

  • 04262358420060 ()
  • 04262358420039 ()
  • 04262358420121 ()

  • suitable for stapler size 31/32
MP0031/32

  • Endoscopic-access dilator, single-use

m-protect3 - 04262358420022

m-protect®3 is intended exclusively for use as an insertion guide of circular stapler instruments used for transanal stapled anastomosis.
qtec CE-med GmbH
28/29
In Commercial Distribution

  • 04262358420022 ()
  • 04262358420114 ()

  • suitable for stapler size 28/29
MP0028/29

  • Endoscopic-access dilator, single-use

MedibinoNEO ring – TG PUR Gel - Size M - PU6 - 04260764840564

Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840564 ()
  • 04260764840717 ()

  • Fits for premature infants weighting 800-2000g
24021703-M

  • Infant recumbent sleep positioner

Urine Calibrator Set - 04250317542342

6PLUS1® Multilevel Urine Calibrator Set MassTox® Drugs of Abuse Testing in urine
Chromsystems Instruments + Chemicals GmbH
96040
In Commercial Distribution

  • 04250317542342 ()

  • Total Volume: 1 Milliliter
  • 1 vial for each calibrator level
96040

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator

iLESSYS® - 04250337115267

Scope Working Tube Distance Ring iLESSYS® Delta
Joimax GmbH
SWTDR1009
In Commercial Distribution

  • 04250337115267 ()

  • for Endoscopes with OD 10 mm
SWTDR1009

  • Spinal endoscopic-access system

mounting clip - 04250337108566

Mounting Clip
Joimax GmbH
JMPS198BFC
In Commercial Distribution

  • 04250337108566 ()

  • for Screw Inserter and Bone Filler
JMPS198BFC

  • General internal orthopaedic fixation system implantation kit

Arthroscopy sieve - 04250337105367

Arthroscope Tray
Joimax GmbH
AST221450
In Commercial Distribution

  • 04250337105367 ()

  • suitable for Arthroscopes L 110 mm
AST221450

  • Instrument tray, reusable

TatumSurgical/Large Ball Housing - 00083208350009

Large Ball Housing
Suncoast Dental, Inc
Large Ball Housing
In Commercial Distribution

  • 00083208350009 ()

  • Large Ball Housing for 3.5mm Ball
HBP-L

  • Resilient dental precision attachment

TatumSurgical/Small Ball Housing - 00083208200014

Small Ball Housing
Suncoast Dental, Inc
Small Ball Housing
In Commercial Distribution

  • 00083208200014 ()

  • Small Ball Housing for 2mm Ball
HBP-S

  • Resilient dental precision attachment

V-TEK™ - 00889024107649

No Description
Zimmer GmbH
28.10.140
In Commercial Distribution

  • 00889024107649 ()

  • for plates Offset, straight, Sys.3.5


  • General internal orthopaedic fixation system implantation kit

V-TEK™ - 00889024107632

No Description
Zimmer GmbH
28.10.130
In Commercial Distribution

  • 00889024107632 ()

  • for plates, S, L-shape, Sys.2.7


  • General internal orthopaedic fixation system implantation kit

V-TEK™ - 00889024107489

No Description
Zimmer GmbH
28.10.021
In Commercial Distribution

  • 00889024107489 ()

  • for plates M/L, Sys 2.7


  • General internal orthopaedic fixation system implantation kit

V-TEK™ - 00889024107472

No Description
Zimmer GmbH
28.10.019
In Commercial Distribution

  • 00889024107472 ()

  • for plates XS/S, Sys 2.7


  • General internal orthopaedic fixation system implantation kit
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