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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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AHS - B031AH03L0

SYRINGE,3CC L/L
American Health Service Sales Corporation
AH03L
In Commercial Distribution

  • B031AH03L2 ()
  • B031AH03L1 ()
  • B031AH03L0 ()


  • General-purpose syringe, single-use

AHS - B031AH01T27130

SYRINGE,1CC 27 X 1/2,LUER SLIP,TB
American Health Service Sales Corporation
AH01T2713
In Commercial Distribution

  • B031AH01T27132 ()
  • B031AH01T27131 ()
  • B031AH01T27130 ()


  • General-purpose syringe, single-use

AHS - B031AH01T25160

SYRINGE,1CC 25 X 5/8,LUER SLIP,TB
American Health Service Sales Corporation
AH01T2516
In Commercial Distribution

  • B031AH01T25162 ()
  • B031AH01T25161 ()
  • B031AH01T25160 ()


  • General-purpose syringe, single-use

AHS - B031AH01T0

SYRINGE,1CC, LUER SLIP
American Health Service Sales Corporation
AH01T
In Commercial Distribution

  • B031AH01T0 ()
  • B031AH01T1 ()
  • B031AH01T2 ()


  • General-purpose syringe, single-use

CosmoLock Pedicle Screw System - B07311LCL00000

Locking Cap
Kalitec Direct LLC
11-LCL-0000
In Commercial Distribution

  • B07311LCL00000 ()
  • B07311LCL00002 ()
  • B07311LCL00001 ()


  • Bone-screw internal spinal fixation system, non-sterile

MAWI - B353MA12511

Wearable Biosensor - ECG Remote Monitoring Biosensor Patch
Lifesignals, Inc.
MA1251
Not in Commercial Distribution

  • B353MA12512 ()
  • B353MA12511 ()
  • B353MA12513 ()
MA1251_US

  • Electrocardiography telemetric monitoring system

Fascile Continuous Peripheral Nerve Block Set - B372500001011

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure.
Solo-Dex, Inc
70mm, Kit with filter
Not in Commercial Distribution

  • B3723000301015 ()
  • B372500001011 ()
  • B3721001385 ()

  • Length: 70 Millimeter
500001-01

  • Peripheral nerve-block sharp needle

Perineologic - B371P10010

The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposable, needle guide consisting, of a Carriage and a Rail Clamp Assembly and Access Needle, that is intended for use with a cylindrical style trans-rectal ultrasound transducer (0.7” to .85” diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system and a biopsy needle. The PrecisionPoint™ Transperineal Access System is designed to stabilize a Perineologic Access Needle on the anatomy as a means to properly guide the anatomical placement of a biopsy needle into the prostate or other soft tissues through the use of ultrasound-assisted guidance.
Corbin Clinical Resources, LLC
1
In Commercial Distribution

  • B371P10010 ()
  • B371P10012 ()
  • B371P10014 ()


  • Needle guide, single-use

IB-STIM - B327NSS203

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 weighing approximately 5 grams 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.
KEY ELECTRONICS, INC.
IB-STIM
In Commercial Distribution

  • B327NSS2032 ()
  • B327NSS203 ()
  • B327NSS2031 ()
01-1020

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator

NSS MFS - B327NSS202

The NSS Military Field Stimulator (MFS) ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS MFS is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS MFS is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS MFS offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
MFS
In Commercial Distribution

  • B327NSS202 ()
  • B327NSS2022 ()
  • B327NSS2021 ()
01-1011-NSS/MFS

  • Acupuncture electrical stimulation system
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