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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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RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
5I4110U-101043A
In Commercial Distribution

  • 00840828182133 ()
26495

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
5I4119U-101043A
In Commercial Distribution

  • 00840828182119 ()
26450

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
5I4119U-101033A
In Commercial Distribution

  • 00840828182102 ()
26449

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
5I41TU-901421A
In Commercial Distribution

  • 00840828182096 ()
26477

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
5I41MU-163410A
In Commercial Distribution

  • 00840828182065 ()
26494

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
5I4118U-164033A
In Commercial Distribution

  • 00840828182041 ()
26466

  • Pillow speaker
RESPONDER 5, INTERACTIVE
CURBELL MEDICAL PRODUCTS, INC.
5I41WU-101033A
In Commercial Distribution

  • 00840828182010 ()
26474

  • Pillow speaker
Bioactive dentin substitute
SEPTODONT SAS SPECIALITES SEPTODONT
01C0605
In Commercial Distribution

  • 03760140703366 ()
01C0605

  • Hygroscopic dental cement
No Description
Roche Diagnostics GmbH
06331092190
In Commercial Distribution

  • 04015630946204 ()
06331092190

  • Anti-Mullerian hormone (AMH) IVD, calibrator
Rapid test for the detection of carbapenemases KPC, OXA, VIM, IMP and NDM in a bacterial colony from culture.
NG BIOTECH
Kit of 20 tests for US
In Commercial Distribution

  • 03701077400133 ()
  • 03701077400140 ()
NGB-CAR-S23-018

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit
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