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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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MABIS DMI - 00041298400103

OB KIT - STANDARD WITH STERILE SCAPEL
D-M-S HOLDINGS, INC.
650-4001-0000
Not in Commercial Distribution

  • 10041298400100 ()
  • 00041298400103 ()
650-4001-0000

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

Amplatz - 00827002460324

Clear Amplatz Sheath With Radiopaque Stripe
COOK INCORPORATED
G46032
In Commercial Distribution

  • 00827002460324 ()
CAS-300017

  • Non-vascular catheter introduction set

Amplatz - 00827002460317

Clear Amplatz Sheath With Radiopaque Stripe
COOK INCORPORATED
G46031
In Commercial Distribution

  • 00827002460317 ()
CAS-240017

  • Non-vascular catheter introduction set

Amplatz - 00827002460300

Clear Amplatz Sheath With Radiopaque Stripe
COOK INCORPORATED
G46030
In Commercial Distribution

  • 00827002460300 ()
CAS-180017

  • Non-vascular catheter introduction set

Tri-Ex - 00827002268579

Tri-Ex Extraction Balloon with Multiple Sizing
COOK INCORPORATED
G26857
In Commercial Distribution

  • 00827002268579 ()
TXR-8.5-12-15-B

  • ERCP catheter, balloon, non-electrical, stone-retrieval

Tri-Ex - 00827002268562

Tri-Ex Extraction Balloon with Multiple Sizing
COOK INCORPORATED
G26856
In Commercial Distribution

  • 00827002268562 ()
TXR-8.5-12-15-A

  • ERCP catheter, balloon, non-electrical, stone-retrieval

Soft-Trans - 00827002261792

Soft-Trans Trial Catheter With Guide Catheter
COOK INCORPORATED
G26179
Not in Commercial Distribution

  • 00827002261792 ()
K-SOFT-5012

  • Assisted reproduction transfer catheter/set

Ultraxx - 00827002303645

Ultraxx Nephrostomy Balloon With TFE Sheath
COOK INCORPORATED
G30364
In Commercial Distribution

  • 00827002303645 ()
UNB-10-15

  • Nephrostomy catheter

Keller-Timmermans - 00827002301740

Keller-Timmermans Introducer Set with Rutner Adapter
COOK INCORPORATED
G30174
In Commercial Distribution

  • 00827002301740 ()
VSSW-24.0-38-30-0-KTI

  • Vascular catheter introduction set, nonimplantable

Keller-Timmermans - 00827002289802

Keller-Timmermans Introducer Set with Rutner Adapter
COOK INCORPORATED
G28980
In Commercial Distribution

  • 00827002289802 ()
VSSW-24.0-38-85-0-KTI

  • Vascular catheter introduction set, nonimplantable
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