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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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ROYLA FLUSH - BHRF13501140

(8"-12") Royal Flush 2,3,5 Ply White Heavy X-Large No Hole 12 Pack
Royal Knit, Inc.
BHRF135-01-14
In Commercial Distribution

  • BHRF13501140 ()
BHRF135-01-14

  • Stump sock

ROYLA FLUSH - BHRF13501120

(12"-14") Royal Flush 2,3,5 Ply White X-Large With Reinforced Hole 12 Pack
Royal Knit, Inc.
BHRF135-01-12
In Commercial Distribution

  • BHRF13501120 ()
BHRF135-01-12

  • Stump sock

ROYLA FLUSH - BHRF13501100

(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

BlackBox RPM - B963PO401W1

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

  • BB4B963PO401W1 ()
  • B963PO401W1 ()


  • Pulse oximeter

NSS IB-STIM - B960NSS203

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

Oxxiom - B944TWPD1DA0320150

Wireless, Disposable, Single-Use Pulse Oximetry System
TRUE WEARABLES, INC.
1612
In Commercial Distribution

  • B944TWPD1DA0320150 ()
TWPD1DA032015

  • Pulse oximeter

Universal Funnel Adapter - H862UFALL0

Universal Funnel Adapter-Luer Lock
URESIL, LLC
UFA-LL
In Commercial Distribution

  • H862UFALL2 ()
  • H862UFALL0 ()
UFA-LL

  • Luer/non-ISO80369-standardized linear connector, single-use

Aspiration and Flush Assembly - H862AFALB0

ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM
URESIL, LLC
AFA-LB
In Commercial Distribution

  • H862AFALB2 ()
  • H862AFALB1 ()
  • H862AFALB0 ()
AFA-LB

  • Luer/non-ISO80369-standardized linear connector, single-use

Aspiration and Flush Assembly - H862AFA20P0

ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM WITH FUNNEL
URESIL, LLC
AFA-20P
Not in Commercial Distribution

  • H862AFA20P2 ()
  • H862AFA20P1 ()
  • H862AFA20P0 ()
AFA-20P

  • Luer/non-ISO80369-standardized linear connector, single-use

M.A.S.S. Traction Belt - G505MRTB0

2-part belt for providing lumbar traction.
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRTB0 ()


  • Traction system belt
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