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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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Protect U Guard Silicone Foam Sterile Dressing 15x15cm
PROTECT U GUARD, LLC
P19132
In Commercial Distribution

  • B086291322 ()
  • B086191321 ()
  • B086091320 ()

  • Width: 15 Centimeter
  • Length: 15 Centimeter


  • Exudate-absorbent dressing, non-gel, non-antimicrobial
Protect U Guard CPE Isolation Gown
PROTECT U GUARD, LLC
P10505
In Commercial Distribution

  • B086205052 ()
  • B086105051 ()
  • B086005050 ()


  • Isolation gown, single-use
No Description
U Smile Dental LLC
LX-A
In Commercial Distribution

  • 90860006415429 ()


  • Orthodontic progressive aligner
No Description
U Smile Dental LLC
Spanish
In Commercial Distribution

  • 00860006415495 ()


  • Dental impression material kit, single-use
No Description
U Smile Dental LLC
12021
In Commercial Distribution

  • 00860006415488 ()


  • Dental impression material kit, single-use
D Cap Gravity Feeding Set with ENFit Connector
U DELIVER MEDICAL L.L.C.
BK-2260
In Commercial Distribution

  • 00860136002466 ()
  • 00860136002473 ()


  • Enteral feeding noninvasive-component set
Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector
U DELIVER MEDICAL L.L.C.
BK-2085
In Commercial Distribution

  • 00860136002435 ()
  • 10860136002425 ()
BK-2085

  • Enteral feeding kit, adult/paediatric, non-sterile
Large Cap Gravity Feeding Set with Cross Spike and ENFit Connector
U DELIVER MEDICAL L.L.C.
BK-2405
In Commercial Distribution

  • 00860136002428 ()


  • Enteral feeding kit, adult/paediatric, non-sterile
bFed Refill kit containing 10 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 4 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 7 375 mL Bolee™ Bags
U DELIVER MEDICAL L.L.C.
SK-2002
In Commercial Distribution

  • 00867622000456 ()
  • 00867622000470 ()
SK-2002

  • Enteral feeding kit, adult/paediatric, non-sterile
bFed Starter kit containing 5 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 2 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 3 375 mL Bolee™ Bags
U DELIVER MEDICAL L.L.C.
SK-2001
In Commercial Distribution

  • 00867622000449 ()
  • 00867622000463 ()
SK-2001

  • Enteral feeding kit, adult/paediatric, non-sterile
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