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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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ZILIENT - 10852528005480

4gram tip, short taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
04G-300-018
Not in Commercial Distribution

  • 30852528005484 ()
  • 10852528005480 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 4 grams; Length: 300cm
7-10049-04

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005473

4gram tip, short taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
04G-195-018
Not in Commercial Distribution

  • 10852528005473 ()
  • 30852528005477 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 4 grams; Length: 195cm
7-10049-03

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568681

0.018" Shepherd ES Guidewire - straight 300 cm - 30 gms
Cardiovascular Systems, Inc.
PSP18S-30030
In Commercial Distribution

  • 30850026568685 ()
  • 10850026568681 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 30 grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-08

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568674

0.018" Shepherd ES Guidewire - straight 195 cm - 30 gms
Cardiovascular Systems, Inc.
PSP18S-19530
In Commercial Distribution

  • 30850026568678 ()
  • 10850026568674 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 30 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-07

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568667

0.014" Shepherd ES Guidewire - straight 300 cm - 30 gms
Cardiovascular Systems, Inc.
PSP14S-30030
In Commercial Distribution

  • 30850026568661 ()
  • 10850026568667 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Tip Flex 30 Grams
  • Tip Shape Straight
  • Hydrophilic Coating
  • Tip Design Polymer Jacket
7-10097-06

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568650

0.014" Shepherd ES Guidewire - straight 195 cm - 30 gms
Cardiovascular Systems, Inc.
PSP14S-19530
In Commercial Distribution

  • 30850026568654 ()
  • 10850026568650 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 30 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-05

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568643

0.018" Shepherd ES Guidewire - straight 300 cm - 12 gms
Cardiovascular Systems, Inc.
PSP18S-30012
In Commercial Distribution

  • 30850026568647 ()
  • 10850026568643 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-04

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568636

0.018" Shepherd ES Guidewire - straight 195 cm - 12 gms
Cardiovascular Systems, Inc.
PSP18S-19512
In Commercial Distribution

  • 30850026568630 ()
  • 10850026568636 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-03

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568629

0.014" Shepherd ES Guidewire - straight 300 cm - 12 gms
Cardiovascular Systems, Inc.
PSP14S-30012
In Commercial Distribution

  • 30850026568623 ()
  • 10850026568629 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-02

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568612

0.014" Shepherd ES Guidewire - straight 195 cm - 12 gms
Cardiovascular Systems, Inc.
PSP14S-19512
In Commercial Distribution

  • 30850026568616 ()
  • 10850026568612 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 12 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10097-01

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568605

0.018" Shepherd ES Guidewire - straight 300 cm - 6 gms
Cardiovascular Systems, Inc.
PSP18S-30006
In Commercial Distribution

  • 30850026568609 ()
  • 10850026568605 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydorphilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-08

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568599

0.018" Shepherd ES Guidewire - straight 195 cm - 6 gms
Cardiovascular Systems, Inc.
PSP18S-19506
In Commercial Distribution

  • 30850026568593 ()
  • 10850026568599 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 195 Centimeter
  • Hydrdophilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-07

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568582

0.014" Shepherd ES Guidewire - straight 300 cm - 6 gms
Cardiovascular Systems, Inc.
PSP14S-30006
In Commercial Distribution

  • 30850026568586 ()
  • 10850026568582 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-06

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568575

0.014" Shepherd ES Guidewire - straight 195 cm - 6 gms
Cardiovascular Systems, Inc.
PSP14S-19506
In Commercial Distribution

  • 30850026568579 ()
  • 10850026568575 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Centimeter
  • Hydrophilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-05

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568568

0.018" Shepherd ES Guidewire - straight 300 cm - 4 gms
Cardiovascular Systems, Inc.
PSP18S-30004
In Commercial Distribution

  • 30850026568562 ()
  • 10850026568568 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 4 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-04

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568551

0.018" Shepherd ES Guidewire - straight 195 cm - 4 gms
Cardiovascular Systems, Inc.
PSP18S-19504
In Commercial Distribution

  • 30850026568555 ()
  • 10850026568551 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 195 Centimeter
  • Hydorphilic Coating
  • Tip Flex 4 grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-03

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568544

0.014" Shepherd ES Guidewire - straight 300 cm - 4 gms
Cardiovascular Systems, Inc.
PSP14S-30004
In Commercial Distribution

  • 10850026568544 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 4 grams
  • Tip Shape Straighht
  • Tip Design Polymer Jacket
7-10096-02

  • Peripheral vascular guidewire, manual

Shepherd - 10850026568537

0.014" Shepherd ES Guidewire - straight 195 cm - 4 gms
Cardiovascular Systems, Inc.
PSP14S-19504
In Commercial Distribution

  • 30850026568531 ()
  • 10850026568537 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Inch
  • Hydrophilic Coating
  • Tip Flex 4 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-01

  • Peripheral vascular guidewire, manual

Halyard Basics - 30885632437537

Underpad Incontinence Disposable 30in x 36in Non Woven White Heavy Absorbency CA/40 White 40/CA 300 lb Weight Rating Not made with Natural Rubber Latex Halyard Basics
OWENS & MINOR DISTRIBUTION, INC.
49515
In Commercial Distribution

  • 20885632437530 ()
  • 30885632437537 ()
  • 10885632437533 ()


  • Absorbent underpad, non-antimicrobial, single-use

MALDI Biotyper sirius CA System - 04251204326168

Biotyper system for clinical use in the USA, with smartbeam laser.
Bruker Daltonik GmbH
1890132
In Commercial Distribution

  • 04251204326168 ()
1890132

  • Microbial identification mass spectrometry system IVD

MALDI Biotyper-BD sirius CA System - 04251204326175

Biotyper system for clinical use in the USA, with smartbeam laser.
Bruker Daltonik GmbH
1890133
In Commercial Distribution

  • 04251204326175 ()
1890133

  • Microbial identification mass spectrometry system IVD

AIA-PACK CA 125 Calibrator Set - 04560189211148

No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211148 ()


  • Cancer antigen 125 (CA125) IVD, calibrator

AIA-PACK CA 19-9 Calibrator Set - 04560189211117

No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211117 ()


  • Cancer antigen 19-9 (CA19-9) IVD, calibrator

Lumipulse G CA 19-9-N Calibrators - 04987270230664

No Description
FUJIREBIO INC.
230664
Not in Commercial Distribution

  • 04987270230664 ()

  • Size Type = Units per Kit; Units = 2; Unit of Measure = 3.0 mLs


  • Cancer antigen 19-9 (CA19-9) IVD, calibrator

Lumipulse G CA 15-3 Calibrators - 04987270230640

No Description
FUJIREBIO INC.
230640
In Commercial Distribution

  • 04987270230640 ()

  • Size Type = Units per kit; Units = 2; Unit of Measure = 3.0 mLs


  • Cancer antigen 15-3 (CA15-3) IVD, calibrator

RAPIDPOINT® 350 Ca++ Electrode - 00630414566771

RAPIDPOINT® 350 Calcium Electrode, for use with RapidPoint® 350 analyzer
Siemens Healthcare Diagnostics Inc.
10376547
In Commercial Distribution

  • 00630414566771 ()
10376547

  • Calcium (Ca2+) electrode IVD

Atellica IM CA 19-9 MCM - 00630414598192

CA 19-9 Atellica IM - Master Curve Material Kit 8 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995492
In Commercial Distribution

  • 00630414598192 ()
10995492

  • Cancer antigen 19-9 (CA19-9) IVD, control

Atellica IM CA 15-3 MCM - 00630414598154

CA 15-3 Atellica IM Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995488
In Commercial Distribution

  • 00630414598154 ()
10995488

  • Cancer antigen 15-3 (CA15-3) IVD, control

Atellica IM CA 125II MCM - 00630414598116

CA 125II - Atellica IM - Master Curve Material Kit 8 x 1 x 1.0 mL
Siemens Healthcare Diagnostics Inc.
10995484
In Commercial Distribution

  • 00630414598116 ()
10995484

  • Cancer antigen 125 (CA125) IVD, control

FILMARRAY NGDS WARRIOR PANEL - CA - 00851458005266

FILMARRAY NGDS Warrior Panel - CA - IVD reagent kit containing 30 tests (Health Canada licensed version)
BIOFIRE DEFENSE, LLC
DFA2-ASY-0012
In Commercial Distribution

  • 00851458005266 ()
DFA2-ASY-0012

  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Argus II Communication Adapter (CA) - 00850052743055

A device which provides data communication and electrical isolation between the Video Processing Unit and the Clinician Programming System.
CORTIGENT, INC.
014103-002
Not in Commercial Distribution

014103

  • Retinal prosthesis system tester/clinical evaluator

KIT CA ENDO + License Code - J00717007330011

Set of Optima contre angle and licence code for settings
Bien-Air Dental SA
1700733-001
In Commercial Distribution

  • J00717007330011 ()
1700733-001

  • Surgical power tool system control unit, line-powered

Set iOptima + CA +:5L MS - J00717005690011

Sets of iOptima systems and their dental micromotors plus relevant accessories
Bien-Air Dental SA
1700569-001
In Commercial Distribution

  • J00717005690011 ()
1700569-001

  • Surgical power tool system control unit, line-powered

Set Chiropro + CA 20:1 - J00717003880011

Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories
Bien-Air Dental SA
1700388-001
In Commercial Distribution

  • J00717003880011 ()
1700388-001

  • Surgical power tool system control unit, line-powered

CA PRIMA 1:1 L - J00716012360011

Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric or air micromotor.
Bien-Air Dental SA
1601236-001
In Commercial Distribution

  • J00716012360011 ()


  • Dental laboratory drilling system handpiece

CA 1:2.5 L MS - J00716011640011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601164-001
In Commercial Distribution

  • J00716011640011 ()
1601164-001

  • Dental laboratory drilling system handpiece

CA NOVA 1:5L MS - J00716011380011

CA & HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor’s speed.
Bien-Air Dental SA
1601138-001
In Commercial Distribution

  • J00716011380011 ()
1601138-001

  • Dental power tool system handpiece, remotely-driven

CA NOVA 1:1 L - J00716011370011

CA & HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor’s speed
Bien-Air Dental SA
1601137-001
In Commercial Distribution

  • J00716011370011 ()
1601137-001

  • Dental power tool system handpiece, remotely-driven

CA NOVA 1:1L MS - J00716011360011

CA & HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor’s speed
Bien-Air Dental SA
1601136-001
In Commercial Distribution

  • J00716011360011 ()
1601136-001

  • Dental power tool system handpiece, remotely-driven

CA 1:5 L Lares - J00716010580011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601058-001
In Commercial Distribution

  • J00716010580011 ()
1601058-001

  • Pneumatic dental handpiece coupler

CA 1:1 L Lares - J00716010570011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601057-001
In Commercial Distribution

  • J00716010570011 ()
1601057-001

  • Dental power tool system handpiece, remotely-driven

CA 1:2.5 L MS - J00716010550011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601055-001
In Commercial Distribution

  • J00716010550011 ()
1601055-001

  • Dental power tool system handpiece, remotely-driven

CA NOVA 1:1L MS - J00716010110011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601011-001
In Commercial Distribution

  • J00716010110011 ()
1601011-001

  • Dental power tool system handpiece, remotely-driven

PM CA 1:5L EVO15 - J00716009410011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600941-001
In Commercial Distribution

  • J00716009410011 ()
1600941-001

  • Dental power tool system handpiece, remotely-driven

CA 1:1 L EVO15 - J00716009390011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600939-001
In Commercial Distribution

  • J00716009390011 ()
1600939-001

  • Dental power tool system handpiece, remotely-driven

CA 20:1 LKM Micro-Series - J00716008740011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600874-001
In Commercial Distribution

  • J00716008740011 ()
1600874-001

  • Dental laboratory drilling system handpiece

CA 20:1 L KM - J00716007850011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600785-001
In Commercial Distribution

  • J00716007850011 ()
1600785-001

  • Dental power tool system handpiece, remotely-driven

CA 20:1 L Micro-Series - J00716006920011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600692-001
In Commercial Distribution

  • J00716006920011 ()
1600692-001

  • Dental power tool system handpiece, remotely-driven

CA 1:1 L Micro-Series - J00716006910011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600691-001
In Commercial Distribution

  • J00716006910011 ()
1600691-001

  • Dental power tool system handpiece, remotely-driven

CA 1:5 L Micro-Series - J00716006900011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600690-001
In Commercial Distribution

  • J00716006900011 ()
1600690-001

  • Dental power tool system handpiece, remotely-driven
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