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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Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided.
Sonic Incytes Medical Corp.
LI-1005
In Commercial Distribution

  • B995LI10050 ()


  • Hepatic ultrasound elastography system
The MediByte Jr. is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a warranty replacement unit.
Braebon Medical Corporation
MBJR-W
In Commercial Distribution

  • B140MBJRW0 ()
MBJR-W

  • Polysomnograph
Allen key 3.5 mm is a hand-held instrument used to hold or unhold screw on the extraction clamp and the chisel handle. This is a hexagonal tip of 3.5 mm.This is a reusable device.
MPS Micro Precision Systems AG
T14927
In Commercial Distribution

  • 07640187910476 ()
T14927

  • Surgical screwdriver, reusable
The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a new warranty replacement unit.
Braebon Medical Corporation
MP8-WN
In Commercial Distribution

  • B140MP8WN0 ()
MP8-WN

  • Polysomnograph
The Genotropin Mixer is a device used to mix growth hormone that is provided in a Two-Chamber Cartridge (TCC). The Genotropin Mixer is a non-sterile, reusable medical device designed for mixing the Genotropin TCC.
PFIZER INC.
F000092379
In Commercial Distribution

  • 10300130923796 ()


  • Basic growth hormone autoinjector, replaceable-cartridge
Material on this Purchase Order is managed via SMI. The delivery schedule is determined by the Supplier per the SMI stocking limits and not by this Purchase Order. Quantity shown is for reference only.
Philips Medical Systems Hsg
Smart CapnoLine H O2 Adult
Not in Commercial Distribution

  • 20884838071050 ()
  • 00884838071056 ()
989803177951

  • Nasal oxygen cannula, carbon-dioxide-sampling
The SuperPole F.R.S. is a high quality, commercial grade support pole that interfaces with and is supported by a receptacle that is permanently embedded into a structural concrete floor. The SuperPole F.R.S. is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. When the pole is removed, the receptacle must be covered with a floor flush cap to provide a water-tight seal. The maximum user weight for this product is 450lbs / 205kgs. Product is not intended to support full body weight. The SuperPole F.R.S. is not to be used in any other way than described
Healthcraft Products Inc.
FRS-P
In Commercial Distribution

  • 00689281005128 ()
00512

  • Fixed-rail armrest
NEUROTUBE is designed for primary or secondary peripheral nerve repair or reconstruction. The NEUROTUBE device is resorbed through the process of hydrolysis.
SYNOVIS MICRO COMPANIES ALLIANCE, INC
GEM0420NT
In Commercial Distribution

  • 00844735006193 ()

  • Length: 20 Millimeter
  • Lumen/Inner Diameter: 4.0 Millimeter
531101420011

  • Nerve guide, synthetic polymer, bioabsorbable
The LED Light Therapy Mask (Model:MK66R-B) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
MK66R-B
In Commercial Distribution

  • 00655729008235 ()


  • Cosmetic red-light phototherapy system, home-use
The 50EW is a rechargeable pulse oximeter that is designed to accurately measure oxygen saturation (SpO2) and pulse rate through your finger.
LORTE TECHNOLOGIES, INC
CMS-50EW with Bluetooth
In Commercial Distribution

  • 00851908007062 ()


  • Pulse oximeter
Model WL-2407Rx is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain.
WELL-LIFE HEALTHCARE LTD.
WL-2407Rx
Not in Commercial Distribution

  • 04719872264088 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
Syringe with Safety Needle is Luer Lock syringe with hinged-cap safety needle. This device is used for aspiration and administration of medication.
HTL STREFA S A
1mL 25Gx1”
In Commercial Distribution

  • 05903999600327 ()
  • 15903999600324 ()
  • 25903999600321 ()
6073

  • General-purpose syringe/needle
  • Needle guard
Syringe with Safety Needle is Luer Lock syringe with hinged-cap safety needle. This device is used for aspiration and administration of medication.
HTL STREFA S A
3mL 25Gx1”
In Commercial Distribution

  • 05903999600310 ()
  • 15903999600317 ()
  • 25903999600314 ()
6072

  • General-purpose syringe/needle
  • Needle guard
Parasym is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
EasyMed Instruments Co., Ltd.
Parasym
Not in Commercial Distribution

  • 06942808291027 ()


  • Analgesic transcutaneous electrical nerve stimulation system
MT-11 is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
EasyMed Instruments Co., Ltd.
MT-11
Not in Commercial Distribution

  • 06942808221109 ()


  • Analgesic transcutaneous electrical nerve stimulation system
PowerTENS is a Transcutaneous Electrical Nerve Stimulator, which is used to provide symptomatic pain relief for chronic, acute or post operative pain.
EasyMed Instruments Co., Ltd.
PowerTENS
In Commercial Distribution

  • 06942808221093 ()


  • Analgesic transcutaneous electrical nerve stimulation system
Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the five (5) microplate product.
IMMUCOR, INC.
0066251
In Commercial Distribution

  • 10888234001300 ()
0066251

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Magenta
In Commercial Distribution

  • 04099702079632 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Green
In Commercial Distribution

  • 04099702079618 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Gray
In Commercial Distribution

  • 04099702079519 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Black
In Commercial Distribution

  • 04099702079496 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Starlight
In Commercial Distribution

  • 04099702079472 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
The laser system is an ophthalmologic system based on femtosecond technology. It is used to treat a wide variety of ophthalmologic indications.
Technolas Perfect Vision GmbH
3.2
In Commercial Distribution

  • 04050555002895 ()
14000

  • Femtosecond ophthalmic solid-state laser system
This cuff is a sterile, single use product. This part number is a 44 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-107-00
In Commercial Distribution

  • M995607975107003 ()
  • M995607975107001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 34 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-106-00
In Commercial Distribution

  • M995607975106003 ()
  • M995607975106001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 30 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-105-00
In Commercial Distribution

  • M995607975105003 ()
  • M995607975105001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 24 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-104-00
In Commercial Distribution

  • M995607975104003 ()
  • M995607975104001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 18 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-103-00
In Commercial Distribution

  • M995607975103003 ()
  • M995607975103001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 44 inch model with dual port and single bladder.
Delfi Medical Innovations Inc
60-7970-107-00
In Commercial Distribution

  • M995607970107003 ()
  • M995607970107001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 34 inch model with dual port and single bladder.
Delfi Medical Innovations Inc
60-7970-106-00
In Commercial Distribution

  • M995607970106003 ()
  • M995607970106001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 30 inch model with dual port and single bladder.
Delfi Medical Innovations Inc
60-7970-105-00
In Commercial Distribution

  • M995607970105003 ()
  • M995607970105001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 24 inch model with dual port and single bladder.
Delfi Medical Innovations Inc
60-7970-104-00
In Commercial Distribution

  • M995607970104003 ()
  • M995607970104001 ()


  • Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is an 18 inch model with dual port and single bladder.
Delfi Medical Innovations Inc
60-7970-103-00
In Commercial Distribution

  • M995607970103003 ()
  • M995607970103001 ()


  • Tourniquet cuff, single-use
Quick Cure is intended for use as a light cure bracket adhesive. This is a 5gm Push Syringe of Thin Viscosity Paste.
RELIANCE ORTHODONTIC PRODUCTS INC
QCT
Not in Commercial Distribution

  • D798QCT0 ()
QCT

  • Orthodontic bracket adhesive
BandLok is intended for use as a chemical cure band cement. This is the 6 gm syringe of Part A, natural shade.
RELIANCE ORTHODONTIC PRODUCTS INC
BLSA
In Commercial Distribution

  • D798BLSA0 ()
BLSA

  • Orthodontic bracket adhesive
Excel Fast is intended for use as a bracket adhesive. This is the Fast Set adhesive Part B in a 6gm syringe
RELIANCE ORTHODONTIC PRODUCTS INC
1EFSB
In Commercial Distribution

  • D7981EFSB0 ()
1EFSB

  • Orthodontic bracket adhesive
Stainless Steel Ortho FlexTech Lingual Retention System is intended for use as a Lingual Retainer Wire. This is the Stainless Steel version.
RELIANCE ORTHODONTIC PRODUCTS INC
SSOFT
In Commercial Distribution

  • D798SSOFTSAM0 ()
SSOFT

  • Orthodontic retainer
Stainless Steel Ortho FlexTech Lingual Retention System is intended for use as a Lingual Retainer Wire. This is the Stainless Steel version.
RELIANCE ORTHODONTIC PRODUCTS INC
SSOFT
In Commercial Distribution

  • D798SSOFT0 ()
SSOFT

  • Orthodontic retainer
Stainless Steel Ortho FlexTech Lingual Retention System is intended for use as a Lingual Retainer Wire. This is the Stainless Steel version.
RELIANCE ORTHODONTIC PRODUCTS INC
SSOFT
Not in Commercial Distribution

  • D798SAMSSOFT0 ()
SSOFT

  • Orthodontic retainer
The NeoBridge is intended to anchor and support umbilical catheters. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Large
In Commercial Distribution

  • 00812594010279 ()
  • 10812594010276 ()
N702

  • Wearable percutaneous catheter/tube holder
The NeoBridge is intended to anchor and support umbilical catheters. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Small
In Commercial Distribution

  • 00812594010262 ()
  • 10812594010269 ()
N701

  • Wearable percutaneous catheter/tube holder
The NeoBridge is intended to anchor and support umbilical catheters. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Mico
In Commercial Distribution

  • 00812594010170 ()
  • 10812594010177 ()
N700

  • Wearable percutaneous catheter/tube holder
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Light Gel Etch Bottle. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-023
In Commercial Distribution

  • D801SP650231 ()
65-023

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Light Gel Etch Bottle. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-023 B
In Commercial Distribution

  • D801SP65023B1 ()
65-023

  • Dentine adhesive
A concentrated version of xMAP® Sheath Fluid, when diluted is is the delivery medium of the sample to the optics component.
LUMINEX CORPORATION
40-75680
In Commercial Distribution

  • 00840487100103 ()


  • Multiplex analyser IVD, laboratory
Cadence Talar Sizer Holder is used to hold the Talar Sizer that is used to measure the proper size Talar Dome Trial.
Ascension Orthopedics, Inc.
10203008
In Commercial Distribution

  • M268102030081 ()
  • 10381780240174 ()

  • Large
10203008

  • Orthopaedic implant/instrument assembling device
The extended compression distraction nut is manufactured from stainless steel and is used to secure components in the Integra External Fixation System.
Ascension Orthopedics, Inc.
12224216
In Commercial Distribution

  • 10381780125136 ()

  • .59 in H x .394 in top dia
12224216

  • External orthopaedic fixation system, reusable
The universal joint is made from stainless steel. It is used to aid in the assembly of the Integra External Fixation System.
Ascension Orthopedics, Inc.
12225221
In Commercial Distribution

  • 10381780125433 ()

  • 1.28 in L
12225221

  • External orthopaedic fixation system, reusable
Anti-MUC2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB69510 ()
BSB 6951

  • Mucin IVD, antibody
Anti-MUC2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB69500 ()
BSB 6950

  • Mucin IVD, antibody
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