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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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MARK3 - 00850014374563

Blue Streak Diamond Burs Gross Reduction Taper Short 655.018 Extra Coarse Black - MARK3®
CARGUS INTERNATIONAL, INC
655S-018XC
In Commercial Distribution

  • 00850014374563 ()
655S-018XC

  • Diamond dental bur, reusable

MARK3 - 00850014374556

Blue Streak Diamond Burs Gross Reduction Cylinder Short 652.018 Extra Coarse Black - MARK3®
CARGUS INTERNATIONAL, INC
652S-018XC
In Commercial Distribution

  • 00850014374556 ()
652S-018XC

  • Diamond dental bur, reusable

MARK3 - 00850014374549

Blue Streak Diamond Burs Flat End Taper 848.018 Extra Coarse Black - MARK3®
CARGUS INTERNATIONAL, INC
848-018XC
In Commercial Distribution

  • 00850014374549 ()
848-018XC

  • Diamond dental bur, reusable

MARK3 - 00850014374532

Blue Streak Diamond Burs Round End Taper 855.016 Extra Coarse Black - MARK3®
CARGUS INTERNATIONAL, INC
855-016XC
In Commercial Distribution

  • 00850014374532 ()
855-016XC

  • Diamond dental bur, reusable

MARK3 - 00850014374471

Blue Streak Diamond Burs Round Edge Taper Short 845.026 Coarse Green - MARK3®
CARGUS INTERNATIONAL, INC
845-KR-026C
In Commercial Distribution

  • 00850014374471 ()
845-KR-026C

  • Diamond dental bur, reusable

MARK3 - 00850014374457

Blue Streak Diamond Burs Round Edge Taper 847KR.016 Medium Blue - MARK3®
CARGUS INTERNATIONAL, INC
847KR-016M
In Commercial Distribution

  • 00850014374457 ()
847KR-016M

  • Diamond dental bur, reusable

MARK3 - 00850014374440

Blue Streak Diamond Burs Round Edge Taper 847KR.016 Coarse Green - MARK3®
CARGUS INTERNATIONAL, INC
847KR-016C
In Commercial Distribution

  • 00850014374440 ()
847KR-016C

  • Diamond dental bur, reusable

MARK3 - 00850014374433

Blue Streak Diamond Burs Round Edge Taper Short 847.017 Coarse Green - MARK3®
CARGUS INTERNATIONAL, INC
847KR-017C
In Commercial Distribution

  • 00850014374433 ()
847KR-017C

  • Diamond dental bur, reusable

MARK3 - 00850014374426

Blue Streak Diamond Burs Round Edge Taper 846KR.016 Medium Blue - MARK3®
CARGUS INTERNATIONAL, INC
846KR-016M
In Commercial Distribution

  • 00850014374426 ()
846KR-016M

  • Diamond dental bur, reusable

MARK3 - 00850014374419

Blue Streak Diamond Burs Round Edge Taper Short 845.026 Medium Blue - MARK3®
CARGUS INTERNATIONAL, INC
845KR-026M
In Commercial Distribution

  • 00850014374419 ()
845KR-026M

  • Diamond dental bur, reusable

MARK3 - 00850014374402

Blue Streak Diamond Burs Round Edge Taper Short 845.026 Fine Red - MARK3®
CARGUS INTERNATIONAL, INC
845KR-026F
In Commercial Distribution

  • 00850014374402 ()
845KR-026F

  • Diamond dental bur, reusable

MARK3 - 00850014374389

Blue Streak Diamond Burs Round Edge Taper Short 845.019 Coarse Green - MARK3®
CARGUS INTERNATIONAL, INC
845KR-019C
In Commercial Distribution

  • 00850014374389 ()
845KR-019C

  • Diamond dental bur, reusable

MARK3 - 00850014374372

Blue Streak Diamond Burs Interdental 392.016 Extra Fine Yellow - MARK3®
CARGUS INTERNATIONAL, INC
392-016XF
In Commercial Distribution

  • 00850014374372 ()
392-016XF

  • Diamond dental bur, reusable

MARK3 - 00850014374365

Blue Streak Diamond Burs Interdental 392.016 Fine Red - MARK3®
CARGUS INTERNATIONAL, INC
392-016F
In Commercial Distribution

  • 00850014374365 ()
392-016F

  • Diamond dental bur, reusable

MARK3 - 00850014374358

Blue Streak Diamond Burs Gingival Curettage 878K.018 Coarse Green - MARK3®
CARGUS INTERNATIONAL, INC
878K-018C
In Commercial Distribution

  • 00850014374358 ()
878K-018C

  • Diamond dental bur, reusable

MARK3 - 00850014374341

Blue Streak Diamond Burs Gingival Curettage 878K.016 Coarse Green - MARK3®
CARGUS INTERNATIONAL, INC
878K-016C
In Commercial Distribution

  • 00850014374341 ()
878K-016C

  • Diamond dental bur, reusable

MARK3 - 00850014374334

Blue Streak Diamond Burs Gingival Curettage 878K.014 Coarse Green - MARK3®
CARGUS INTERNATIONAL, INC
878K-014C
In Commercial Distribution

  • 00850014374334 ()
878K-014C

  • Diamond dental bur, reusable

MARK3 - 00850014374327

Blue Streak Diamond Burs Torpedo 878.014 Coarse Green - MARK3®
CARGUS INTERNATIONAL, INC
878-014C
In Commercial Distribution

  • 00850014374327 ()
878-014C

  • Diamond dental bur, reusable

MARK3 - 00850014374310

Blue Streak Diamond Burs Torpedo 878.012 Medium Blue - MARK3®
CARGUS INTERNATIONAL, INC
878-012M
In Commercial Distribution

  • 00850014374310 ()
878-012M

  • Diamond dental bur, reusable

MARK3 - 00850014374303

Blue Streak Diamond Burs Torpedo 878.012 Coarse Green - MARK3®
CARGUS INTERNATIONAL, INC
878-012C
In Commercial Distribution

  • 00850014374303 ()
878-012C

  • Diamond dental bur, reusable

MARK3 - 00850014374297

Blue Streak Diamond Burs Egg 379.018 Medium Blue - MARK3®
CARGUS INTERNATIONAL, INC
379-018M
In Commercial Distribution

  • 00850014374297 ()
379-018M

  • Diamond dental bur, reusable

MARK3 - 00850014374280

Blue Streak Diamond Burs Egg 379.018 Fine Red - MARK3®
CARGUS INTERNATIONAL, INC
379-018F
In Commercial Distribution

  • 00850014374280 ()
379-018F

  • Diamond dental bur, reusable

MARK3 - 00850014374273

Blue Streak Diamond Burs Egg 379.023 Extra Fine Yellow - MARK3®
CARGUS INTERNATIONAL, INC
379-023XF
In Commercial Distribution

  • 00850014374273 ()
379-023XF

  • Diamond dental bur, reusable

MARK3 - 00850014374266

Blue Streak Diamond Burs Egg 379.023 Medium Blue - MARK3®
CARGUS INTERNATIONAL, INC
379-023M
In Commercial Distribution

  • 00850014374266 ()
379-023M

  • Diamond dental bur, reusable

MARK3 - 00850014374259

Blue Streak Diamond Burs Egg 379.023 Fine Red - MARK3®
CARGUS INTERNATIONAL, INC
379-023F
In Commercial Distribution

  • 00850014374259 ()
379-023F

  • Diamond dental bur, reusable

MARK3 - 00850014374242

Blue Streak Diamond Burs Egg 379.023 Coarse Green - MARK3®
CARGUS INTERNATIONAL, INC
379-023C
In Commercial Distribution

  • 00850014374242 ()
379-023C

  • Diamond dental bur, reusable

MARK3 - 00850014374235

Blue Streak Diamond Burs Bud 368.016 Medium Blue - MARK3®
CARGUS INTERNATIONAL, INC
368-016M
In Commercial Distribution

  • 00850014374235 ()
368-016M

  • Diamond dental bur, reusable

MARK3 - 00850014374228

Blue Streak Diamond Burs Bud 368.016 Fine Red - MARK3®
CARGUS INTERNATIONAL, INC
368-016F
In Commercial Distribution

  • 00850014374228 ()
368-016F

  • Diamond dental bur, reusable

MARK3 - 00850014374211

Blue Streak Diamond Burs Bud 368.016 Coarse Green - MARK3®
CARGUS INTERNATIONAL, INC
368-016C
In Commercial Distribution

  • 00850014374211 ()
368-016C

  • Diamond dental bur, reusable

MARK3 - 00850014374204

Blue Streak Diamond Burs Bud 368.023 Extra Fine Yellow - MARK3®
CARGUS INTERNATIONAL, INC
368-023XF
In Commercial Distribution

  • 00850014374204 ()
368-023XF

  • Diamond dental bur, reusable

MARK3 - 00850014374198

Blue Streak Diamond Burs Bud 368.023 Extra Coarse Black - MARK3®
CARGUS INTERNATIONAL, INC
368-023XC
In Commercial Distribution

  • 00850014374198 ()
368-023XC

  • Diamond dental bur, reusable

1BYONE - 00850014261016

No Description
1BYONEPRODUCTS INC.
TMB-1585-BS
In Commercial Distribution

  • 00850014261016 ()
  • 10850014261013 ()


  • Telemetric sphygmomanometer

INTERA - 00850014110154

Intera 3000 Hepatic Artery Infusion Pump OR Prep Kit, Contents: (1) Huber Needle 22 Gauge, (1) Special Bolus Needle, (1) Empty Syringe Barrel with Lid
Intera Oncology Inc.
AP-07004
In Commercial Distribution

  • 00850014110154 ()
AP07004

  • Hypodermic needle, single-use

INTERA - 00850014110147

Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit
Intera Oncology Inc.
AP-03000H
In Commercial Distribution

  • 00850014110147 ()

  • Total Volume: 30 Milliliter
AP03000H

  • Implantable intrathecal infusion pump, nonprogrammable

INTERA - 00850014110130

Intera 3000 Hepatic Artery Infusion Pump OR Prep Kit, Contents: (1) Huber Needle 22 Gauge, (1) Special Bolus Needle, (1) Empty Syringe Barrel with Lid
Intera Oncology Inc.
AP-07004
In Commercial Distribution

  • 00850014110130 ()
AP07004

  • Hypodermic needle, single-use

INTERA - 00850014110093

Intera 3000 Hepatic Artery Infusion Pump Tapered Silicone Rubber Catheter (Radiopaque) with Connector. Contents: (1) Catheter: O.D. 2.3mm tapered to O.D. 1.5mm x I.D. 0.6mm x 51.7cm long with (1) Universal Barbed Connector
Intera Oncology Inc.
IP-37957
In Commercial Distribution

  • 00850014110093 ()
  • 10850014110090 ()

  • Outer Diameter: 2.3 Millimeter
  • Outer Diameter: 1.5 Millimeter
  • Catheter Inner Diameter: 0.6 Millimeter
  • Length: 51.7 Centimeter
IP37957

  • Implantable vascular infusion pump catheter

INTERA - 00850014110079

Refill Kit - Intera 3000
Intera Oncology Inc.
AP-07014US
In Commercial Distribution

  • 00850014110079 ()

  • Needle Gauge: 22 Gauge
AP07014US

  • Hypodermic needle, single-use

INTERA - 00850014110055

Special Bolus Needle for use with Intera 3000 Hepatic Artery Infusion Pump Straight Length 2" (5 cm)
Intera Oncology Inc.
AP-04032-5
In Commercial Distribution

  • 10850014110052 ()
  • 00850014110055 ()

  • Needle Gauge: 20 Gauge
  • Length: 2 Inch
AP040325

  • Hypodermic needle, single-use

INTERA - 00850014110048

Special Bolus Needle for use with Intera 3000 Hepatic Artery Infusion Pump Straight Length 1 3/8" (3.5cm)
Intera Oncology Inc.
AP-04013-5
In Commercial Distribution

  • 10850014110045 ()
  • 00850014110048 ()

  • Needle Gauge: 20 Gauge
  • Length: 1.375 Inch
AP040135

  • Hypodermic needle, single-use

INTERA - 00850014110031

Non-coring (Huber) needle for use with Intera Infusion Pumps, Straight, 22 Gauge, 2 inch
Intera Oncology Inc.
AP-04030
In Commercial Distribution

  • 10850014110038 ()
  • 00850014110031 ()

  • Needle Gauge: 22 Gauge
  • Length: 2 Inch
AP04030

  • Hypodermic needle, single-use

INTERA - 00850014110024

Non-coring (Huber) needle for use with Intera 3000 Hepatic Artery Infusion Pump, Straight, 22 Gauge, 1.5 inch
Intera Oncology Inc.
AP-04011
In Commercial Distribution

  • 10850014110021 ()
  • 00850014110024 ()

  • Length: 1.5 Inch
  • Needle Gauge: 22 Gauge
AP04011

  • Hypodermic needle, single-use

INTERA - 00850014110017

Non-coring (Huber) needle for use with Intera Infusion Pumps, Straight, 22 Gauge, 1 inch
Intera Oncology Inc.
AP-04009
In Commercial Distribution

  • 10850014110014 ()
  • 00850014110017 ()

  • Needle Gauge: 22 Gauge
  • Length: 1 Inch
AP04009

  • Hypodermic needle, single-use

APRO 70 Swift Catheter - 00850014025267

No Description
Alembic, LLC
FG-02133-132-AC
In Commercial Distribution

  • 00850014025267 ()
APRO 70-132

  • Thrombectomy suction catheter

APRO 55 Catheter - 00850014025250

No Description
Alembic, LLC
APRO-55-125
In Commercial Distribution

  • 00850014025250 ()


  • Thrombectomy suction catheter

APRO 70 Swift Catheter - 00850014025229

No Description
Alembic, LLC
FG-02133-132-IC
In Commercial Distribution

  • 00850014025229 ()
APRO-70-132

  • Vascular guide-catheter, single-use

APRO 70 Swift Catheter - 00850014025120

No Description
Alembic, LLC
FG-02133-135-AC
In Commercial Distribution

  • 00850014025120 ()
APRO-70-135

  • Thrombectomy suction catheter

APRO 70 SwiftCatheter - 00850014025113

No Description
Alembic, LLC
FG-02133-125-AC
In Commercial Distribution

  • 00850014025113 ()
APRO-70-125

  • Thrombectomy suction catheter

APRO 55 Intermediate Catheter - 00850014025090

No Description
Alembic, LLC
APRO-55IC-137
In Commercial Distribution

  • 00850014025090 ()


  • Vascular guide-catheter, single-use

APRO 55 Intermediate Catheter - 00850014025083

No Description
Alembic, LLC
APRO-55IC-125
In Commercial Distribution

  • 00850014025083 ()


  • Vascular guide-catheter, single-use

APRO 70 Catheter - 00850014025069

No Description
Alembic, LLC
FG-01016-N32
In Commercial Distribution

  • 00850014025069 ()
APRO 70-132

  • Thrombectomy suction catheter
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