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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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WA Holter System - 90815187020276

HR100 Holter Repair Exchange
GLOBAL INSTRUMENTATION, LLC
HR100
In Commercial Distribution

  • 90815187020276 ()
402810

  • Electrocardiographic ambulatory recorder

CENTRONAIL TITANIUM HUMERAL NAILING SYSTEM - 18032568039740

HUMERAL WIRE EXCHANGE TUBE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568039740 ()
178353

  • General internal orthopaedic fixation system implantation kit

TORQ TNT Exchange Tube - 00810055523719

TORQ TNT Exchange Tube
Si-Bone Inc.
501775
In Commercial Distribution

  • 00810055523719 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Piccolo Composite Nailing System - 07290109339948

Exchange Tube for use with the Piccolo Composite Proximal Femur Nailing System
CARBOFIX ORTHOPEDICS LTD
Exchange Tube
In Commercial Distribution

  • 07290109339948 ()
PFT912240L

  • Orthopaedic implantation sleeve, single-use

Piccolo Composite Nailing System - 07290109338781

Exchange Tube for use with the Piccolo Composite Proximal Femur Nailing System
CARBOFIX ORTHOPEDICS LTD
Exchange Tube
In Commercial Distribution

  • 07290109338781 ()
PFT912240

  • Orthopaedic implantation sleeve, single-use

Centurion - 00653160237771

ARTERIAL LINE INSERTION/EXCHANGE KIT
CENTURION MEDICAL PRODUCTS CORPORATION
CVI3370
In Commercial Distribution

  • 10653160237778 ()
  • 00653160237771 ()
CVI3370

  • Arterial blood sampling kit

Exchange Select One Step Pregnancy Test - 00614299396425

FPPL Exchange Select DPS +/- (ER)
SPD SWISS PRECISION DIAGNOSTICS GMBH
FPPL
In Commercial Distribution

  • 00614299396425 ()
  • 10614299396422 ()
  • 00633472000133 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Heat Moisture Exchanger - 00848530083274

Heat Moisture Exchange Large Volume
SUNSET HEALTHCARE SOLUTIONS, INC.
RES027IL
In Commercial Distribution

  • 00848530083274 ()


  • Heat/moisture exchanger, single-use

NA - 00199150014606

CUSTOM PACK BB10M30R1 OXY EXCHANGE
MEDTRONIC, INC.
BB10M30R1
In Commercial Distribution

  • 00199150014606 ()


  • Cardiopulmonary bypass system blood tubing set

COBE® Spectra - 05020583707009

Red Blood Cell Exchange Set
TERUMO BCT, INC.
70700
In Commercial Distribution

  • 05020583707009 ()
  • 35020583707000 ()
70700

  • Blood transfer set
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