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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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PHILIPS HeartStart FR3 with Text and Small Soft Case - 00884838051454

FR3 Text, US English, Small Soft Bundle
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
860365
Not in Commercial Distribution

  • 00884838051454 ()
860365

  • Non-rechargeable public automated external defibrillator

LAP-BAND® AP System Large with RapidPort® EZ - 00850007764654

LAP-BAND® AP Adjustable Gastric Banding System Large with RapidPort EZ
ReShape Lifesciences Inc.
C-2365
In Commercial Distribution


  • Large
C-2365

  • Gastric band

LAP-BAND® AP System Standard with RapidPort® EZ - 00850007764609

LAP-BAND® AP Adjustable Gastric Banding System Standard with RapidPort EZ
ReShape Lifesciences Inc.
C-2360
In Commercial Distribution


  • Standard
C-2360

  • Gastric band

Mara Water Vapor Probe Kit - 00857379006030

Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline delivery conduit, syringe and saline supply line with spiked end.
AEGEA MEDICAL INC.
DDK-16-050
In Commercial Distribution

  • 00857379006030 ()
DDK-16-050

  • Water vapour endometrial-ablation applicator

CoAxia NeuroFlo™ Catheter - 00849111030007

A multi-lumen device with two balloons mounted near the distal tip.
Zoll Circulation, Inc.
1027
In Commercial Distribution

  • 00849111030007 ()
8700-000775-01

  • Intravascular occluding balloon catheter, image-guided

Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System - 05055715612715

Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBL-98-20-A13-20
In Commercial Distribution

  • 05055715612715 ()


  • Abdominal aorta endovascular stent-graft

Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System - 05055715612708

Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBL-98-18-A13-20
In Commercial Distribution

  • 05055715612708 ()


  • Abdominal aorta endovascular stent-graft

Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System - 05055715612692

Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBL-98-16-A13-20
In Commercial Distribution

  • 05055715612692 ()


  • Abdominal aorta endovascular stent-graft

Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System - 05055715612685

Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBL-98-14-A13-20
In Commercial Distribution

  • 05055715612685 ()


  • Abdominal aorta endovascular stent-graft

Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System - 05055715612678

Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBL-98-12-A13-20
In Commercial Distribution

  • 05055715612678 ()


  • Abdominal aorta endovascular stent-graft
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