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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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85 in. (220 cm) - yellow stripe, For Use with the BodyGuard® Infusion Pump
CME AMERICA LLC
A100-163XESF
Not in Commercial Distribution

  • B101A100163XESF0 ()
  • B101A100163XESF1 ()


  • Electric infusion pump administration set, single-use
bolus cable (1)
CME AMERICA LLC
140-300XP
Not in Commercial Distribution

  • B101140300XP0 ()


  • Bedside infusion pump, single-channel
No Description
CME AMERICA LLC
140-300X
Not in Commercial Distribution

  • B101140300X0 ()


  • Bedside infusion pump, single-channel
UNIVERSAL ARM WITH TABLE CLAMP
SONTEC INSTRUMENTS, INC.
516-828
Not in Commercial Distribution

  • B0995168280 ()


  • Externally-anchored laparoscopic retractor
No Description
BIO CONCEPT Co., Ltd.
152020
In Commercial Distribution

  • 06947600304197 ()


  • Dental implant system
No Description
BIO CONCEPT Co., Ltd.
056070
In Commercial Distribution

  • 06947600302070 ()


  • Dental implant system
Sterilance LDE3 With AST Cap,1pcs/box
SteriLance Medical (Suzhou) Inc.
02-1903
In Commercial Distribution

  • 16945630108751 ()


  • Manual blood lancing device, reusable
This product is used to treat the hemorrhoids in assistance of anoscope for adults only.
Changzhou Health Microport Medical Device Co., Ltd
HM/601-5-B
In Commercial Distribution

  • 06951862291560 ()


  • Haemorrhoid ligation set
This product is used to treat the hemorrhoids in assistance of anoscope for adults only.
Changzhou Health Microport Medical Device Co., Ltd
HM/601-3-A
In Commercial Distribution

  • 06951862291539 ()


  • Haemorrhoid ligation set
Arthrography Tray with Safety Devices
ARGON MEDICAL DEVICES, INC.
A4325SP
Not in Commercial Distribution

  • 20886333220681 ()
  • 00886333220687 ()
A4325SP

  • Arthrogram kit
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