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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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(10"-12") Royal Flush 2,3,5 Ply White X-Large With Reinforced Hole 12 Pack
Royal Knit, Inc.
BHRF135-01-10
In Commercial Distribution

  • BHRF13501100 ()
BHRF135-01-10

  • Stump sock
Pulse Oximeter
Blackbox Remote Patient Monitoring LLC
PO-401W
In Commercial Distribution

  • BB4B963PO401W1 ()
  • B963PO401W1 ()


  • Pulse oximeter
The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population of patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-STIM is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The IB-STIM is placed behind the patient’s ear and connected to stimulation needles on the auricle. The IB-STIM offers regular therapy over several days and is intended to be used for 120 hours per week up to 3 consecutive weeks. The appliance transmits low-frequency electric pulses to exposed nerve endings.
Neuraxis, Inc.
IB-STIM
In Commercial Distribution

  • B960NSS2031 ()
  • B960NSS203 ()
  • B960NSS2032 ()
  • B327NSS203 ()
  • B960NSS2033 ()
01-1020

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
No Description
NXSTAGE MEDICAL, INC.
NX1380
Not in Commercial Distribution

  • M535NX1225NX1380 ()


  • Medical equipment clinical data interfacing software
No Description
NXSTAGE MEDICAL, INC.
NX1379
Not in Commercial Distribution

  • M535NX1225NX1379 ()


  • Medical equipment clinical data interfacing software
No Description
MEDIBLU MEDICAL LLC
MO1
In Commercial Distribution

  • B632MDB01006 ()
MDB01006

  • Pulse oximeter
(8"-12") Royal Flush 2,3,5 Ply Black X-Large With Hole 12 Pack
Royal Knit, Inc.
ORF235-01-14
In Commercial Distribution

  • ORF23501140 ()
ORF235-01-14

  • Stump sock
(10"-12") Royal Flush 2,3,5 Ply Black X-Large No Hole 12 Pack
Royal Knit, Inc.
ORF235-01-10
In Commercial Distribution

  • ORF23501100 ()
ORF235-01-10

  • Stump sock
(8"-12") Royal Flush 2,3,5 Ply Black Heavy X-Large With Hole 12 Pack
Royal Knit, Inc.
OHRF235-01-14
In Commercial Distribution

  • OHRF23501140 ()
OHRF235-01-14

  • Stump sock
(10"-12") Royal Flush 2,3,5 Ply Black Heavy X-Large No Hole 12 Pack
Royal Knit, Inc.
OHRF235-01-10
In Commercial Distribution

  • OHRF23501100 ()
OHRF235-01-10

  • Stump sock
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