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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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Urine Bag - 06936881174100

Exchange Bag 2000ml
Well Lead Medical Co.,Ltd
F04F012010
In Commercial Distribution

  • 26936881174104 ()
  • 06936881174100 ()


  • Wearable adult urine collection bag, open-ended

Exchange Select One Step Pregnancy Test - 00614299396418

Exchange Select SPS
SPD SWISS PRECISION DIAGNOSTICS GMBH
FPPL
In Commercial Distribution

  • 00614299396418 ()
  • 10614299396415 ()


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

Silex Sacroiliac Joint Fusion System - M697X07900891

EXCHANGE PIN, 500mm
Xtant Medical Holdings, Inc.
X079-0089
In Commercial Distribution

  • M697X07900890 ()
  • M697X07900891 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Leksell Gamma Knife Perfexion/Icon - 07340048306591

CC EXCHANGE TOOL
Elekta Instrument AB
1002491
In Commercial Distribution

  • 07340048306591 ()


  • Teletherapy radionuclide system, conventional

R&D Batteries, Inc. - 00810149097355

Baxter 35162 Exchange
R & D Batteries, Inc.
6599
Not in Commercial Distribution

  • 00810149097355 ()


  • Portable/mobile rechargeable battery pack

R&D Batteries, Inc. - 00810149097324

Baxter 35223 Exchange
R & D Batteries, Inc.
6596
Not in Commercial Distribution

  • 00810149097324 ()


  • Portable/mobile rechargeable battery pack

Rocket - 05055270921239

Rocket AmniocentesIs Exchange Set
ROCKET MEDICAL PLC
R57035
In Commercial Distribution

  • 05055270942623 ()
  • 05055270921239 ()
  • 05055270964021 ()

  • Length: 17.0 Centimeter
  • Outer Diameter: 1.473 Millimeter
R57035

  • Chorionic villus sampling needle

Trapper™ Exchange Device - 05391526210154

Trapper™ Exchange Device
CREGANNA UNLIMITED COMPANY
H74939330130
In Commercial Distribution

  • 05391526210154 ()

  • Trapper is designed for use with guide catheters having internal lumen diameters in the range of 6F to 8F
  • Lumen OD: 2.0F (≤0.66mm)
  • Balloon length: 10mm
  • Working length: 97-112cm
H74939330130

  • Coronary angioplasty balloon catheter, basic

Medline Industries, Inc. - 10193489455557

LIPID LINE EXCHANGE KIT
MEDLINE INDUSTRIES, INC.
LC435
In Commercial Distribution

  • 10193489455557 ()
  • 40193489455558 ()
LC435

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

Sterling Medical Products - 00685404001770

NEONATAL EXCHANGE TRANSFUSION TRAY
APOLLO MEDICAL PRODUCTS CORP.
ETT-NW
In Commercial Distribution

  • 10685404001777 ()
  • 00685404001770 ()


  • General surgical procedure kit, medicated
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