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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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International Dental Supply Support Self Cured Core Build-Up Restorative - D801ID55302I1

CuRay Support P/L - Self and Light Cured Core Build-Up Restorative. Part A, Natural Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 55-302 I
In Commercial Distribution

  • D801ID55302I1 ()
55-302

  • Dental composite resin

International Dental Supply Until Temporary Crown and Bridge Cement - D801ID5526I1

Until - An Advanced Eugenol Free Solution for Temporary Crown and Bridge Cementation. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 55-26 I
In Commercial Distribution

  • D801ID5526I1 ()
55-26

  • Glass ionomer dental cement

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50224I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade Universal Opaque Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-224 I
In Commercial Distribution

  • D801ID50224I1 ()
50-224

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50222I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade Incisal Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-222 I
In Commercial Distribution

  • D801ID50222I1 ()
50-222

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50219I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A4 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-219 I
In Commercial Distribution

  • D801ID50219I1 ()
50-219

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50218I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C4 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-218 I
In Commercial Distribution

  • D801ID50218I1 ()
50-218

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50217I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade B2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-217 I
In Commercial Distribution

  • D801ID50217I1 ()
50-217

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50216I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C2 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-216 I
In Commercial Distribution

  • D801ID50216I1 ()
50-216

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50215I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade C3/D3Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-215 I
In Commercial Distribution

  • D801ID50215I1 ()
50-215

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50214I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade B3 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-214 I
In Commercial Distribution

  • D801ID50214I1 ()
50-214

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50213I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A1/B1 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-213 I
In Commercial Distribution

  • D801ID50213I1 ()
50-213

  • Dental composite resin

International Dental Supply CuRay Match Visible Light Cure Composite Restorative - D801ID50212I1

CuRay Match Visible Light Cure Composite Restorative and Veneer Cement Resin-Based Material. Shade A3.5 Syringe. Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 50-212 I
In Commercial Distribution

  • D801ID50212I1 ()
50-212

  • Dental composite resin

MICRO-STICK SETMICRO-STICK SET - 00884908033687

5F (1.0MM ID) X 9CM5F (1.0MM ID) REGULAR MICRO-STICK® INTRODUCER SETINTRODUCER SET WITH NITINOL GUIDEWIREWITH NITIN WITH RADIOPAQUE TIPWITH RADIOPAQ
Medical Components, Inc.
MR190503
Not in Commercial Distribution

  • 50884908033682 ()
  • 30884908033688 ()
  • 00884908033687 ()
MR190503

  • Vascular dilator, single-use

BE 105-2X22D Adapter - M996BE1052X22D0

General Adapter - 22mm ID x 22mm ID adapter for use in breathing/ventilator circuit. Molded of polystyrene butadiene, Single Patient Use.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 105-2X22D
In Commercial Distribution

  • M996BE1052X22D0 ()
  • M996BE1052X22D3 ()
  • M996BE1052X22D6 ()
BE 105-2X22D

  • Straight/elbow breathing circuit connector, single-use

MICRO-STICK SETMICRO-STICK SET - 00884908142433

5F (1.0MM ID) X 9CM5F (1.0MM ID) REGULAR MICRO-STICK® INTRODUCER SET WITHINTRODUCER SE STAINLESS STEEL GUIDEWIRESTAINLE WITH RADIOPAQUE TIPWITH RADIOPAQ
Medical Components, Inc.
DMR190522
In Commercial Distribution

  • 50884908142438 ()
  • 30884908142434 ()
  • 00884908142433 ()
DMR190522

  • Vascular dilator, single-use

MICRO-STICK SETMICRO-STICK SET - 00884908142426

5F (1.0MM ID) X 9CM5F (1.0MM ID) REGULAR MICRO-STICK® INTRODUCER SETINTRODUCER SET WITH NITINOL GUIDEWIREWITH NITIN WITH RADIOPAQUE TIPWITH RADIOPAQ
Medical Components, Inc.
DMR190521
In Commercial Distribution

  • 50884908142421 ()
  • 30884908142427 ()
  • 00884908142426 ()
DMR190521

  • Vascular dilator, single-use

MICRO-STICK SETMICRO-STICK SET - 00884908142419

5F (1.0MM ID) X 9CM5F (1.0MM ID) REGULAR MICRO-STICK® INTRODUCER SETINTRODUCER SET WITH NITINOL GUIDEWIREWITH NITIN WITH RADIOPAQUE TIPWITH RADIOPAQ
Medical Components, Inc.
DMR190503
In Commercial Distribution

  • 30884908142410 ()
  • 00884908142419 ()
  • 50884908142414 ()
DMR190503

  • Vascular dilator, single-use

MICRO-STICK SETMICRO-STICK SET - 00884908142402

4F (1.0MM ID) X 9CM4F (1.0MM ID) REGULAR MICRO-STICK® INTRODUCER SET WITHINTRODUCER SE STAINLESS STEEL GUIDEWIRESTAINLE WITH RADIOPAQUE TIPWITH RADIOPAQ
Medical Components, Inc.
DMR190422
In Commercial Distribution

  • 50884908142407 ()
  • 30884908142403 ()
  • 00884908142402 ()
DMR190422

  • Vascular dilator, single-use

CapsoCloud - 00867770000223

Web-based software for managing the CapsoCam Plus procedures used by health care providers, readers, download centers, and upload centers, also providing online video reviewing and reporting functionalities.
CAPSOVISION, INC.
2
In Commercial Distribution

  • 00867770000223 ()
CLD

  • Video capsule endoscopy system application software

BE 106 Adult Adapter with Vent - M996BE1060

Specialty Adapter with Vent - 15mm ID/22mm OD/15mm ID/22mm OD. Fits components of adult ventilator circuits. Molded of polycarbonate. Reusable.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 106
In Commercial Distribution

  • M996BE1060 ()
BE 106

  • Straight/elbow breathing circuit connector, reusable

SCR REMOVAL TREPHINE 5.5MM ID - 00880304385702

No Description
Biomet Orthopedics, LLC
473684
In Commercial Distribution

  • 00880304385702 ()
473684

  • Screw extractor, reusable

ID upgate kit(RJ45 cable) - 06944904036373

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-011465-00
In Commercial Distribution

  • 06944904036373 ()


  • General-purpose multi-parameter bedside monitor

S-Quadrox iD Plus Pack Softline - 00607567212046

BO-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 1900ml w. connector 700000292, Gas Filter
DATASCOPE CORP.
BO-TOP 8077
In Commercial Distribution

  • 00607567212046 ()
7090000464

  • Cardiopulmonary bypass system blood tubing set

ECC Quadrox iD Pack RF - 00607567212022

BEQ-HMOD 70000-USA Adult Quadrox iD, Blood Transfer Bag 600ml, BEQ- RF32 Rotaflow, Gas Filter, temperature Probe
DATASCOPE CORP.
BEQ-TOP 8013
In Commercial Distribution

  • 00607567212022 ()
701047962R01

  • Cardiopulmonary bypass system blood tubing set

Quadrox iD 7.0 Pack-No RF32 - 00607567210899

BO-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 1900ml w. connector 700000292, Blood Microfilter System SQ 40 S, Gas Filter
DATASCOPE CORP.
BO-TOP 8071
Not in Commercial Distribution

  • 00607567210899 ()
709000342

  • Cardiopulmonary bypass system blood tubing set

ECC Quadrox iD 3/8 - 00607567209985

BEQ-HMOD 70000-USA Adult Quadrox iD, Softshell Venous Reser. 800ml, Blood Transfer Bag 1000 ml - 2 spike ports, Blood Microfilter System SQ 40 S, Prebypass filter w/o Vent Porous Media 3/8x3/8, Gas Filter
DATASCOPE CORP.
BEQ-TOP 22600
Not in Commercial Distribution

  • 00607567209985 ()
701049440R01

  • Cardiopulmonary bypass system blood tubing set

Adult Pack with Quadrox iD - 00607567205536

BEQ-HMOD 70000-USA Adult Quadrox iD, Better Bladder 3/8, BEQ-RF32 RotaFlow, CDI Sat Cell 3/8" System 100, Gas Filter
DATASCOPE CORP.
BEQ-TOP 13505
Not in Commercial Distribution

  • 00607567205536 ()
701065817

  • Cardiopulmonary bypass system blood tubing set

ECC Quadrox ID Pack RF - 00607567203273

BEQ-HMOD 70000- USA Adult Quadrox ID Blood Transfer Bag 600 ml BEQ-RF32 RotaFLow Gas Filter Temperature Probe
DATASCOPE CORP.
BEQ-TOP 8013
Not in Commercial Distribution

  • 00607567203273 ()
701047962

  • Cardiopulmonary bypass system blood tubing set

ECC Pack with Quadrox iD - 00607567203075

BEQ-HMOD 70000 Softshell venous reser Better Bladder BEQ-RF32 CDI Sat Cell Blood Microfilter System Prebypass Filter
DATASCOPE CORP.
BEQ-TOP 35300
Not in Commercial Distribution

  • 00607567203075 ()
70105506

  • Cardiopulmonary bypass system blood tubing set

ECC Quadrox iD 3/8 - 00607567202986

BEQ-HMOD 70000 Softshell Venous Reser Blood Transfer Bag Flow Probe Connector Blood Microfilter System Prebypass filter Gas Filter
DATASCOPE CORP.
BEQ-TOP 22600
Not in Commercial Distribution

  • 00607567202986 ()
701049440

  • Cardiopulmonary bypass system blood tubing set
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