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No Description
Synapse Biomedical, Inc.
22-0034
In Commercial Distribution
- 00852184003458 ()
- Percutaneous electrical stimulation lead external pulse generator cable, reusable
No Description
Merit Pharmaceutical
036319571000
In Commercial Distribution
- 20853620005207 ()
- 10853620005200 ()
- 00853620005203 ()
- Basic intravenous administration set, noninvasive
Syndex with Constrictor® Technology for Syndesmosis Repair
DUNAMIS MEDICAL, LLC
MSYN0000
In Commercial Distribution
- 00854629006727 ()
MSYN0000
- Orthopaedic fixation suture button
- Fluted surgical drill bit, single-use
The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation.
The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005878 ()
DSC014-03-US
- Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005861 ()
D4D0192
- Basic diagnostic x-ray system application software
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
RESPIRE MEDICAL HOLDINGS LLC
SPPD030US
Not in Commercial Distribution
- 00851861007246 ()
- Circumference: 200 Millimeter
- Mandible-repositioning sleep-disordered breathing orthosis
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
RESPIRE MEDICAL HOLDINGS LLC
SPPD000US
Not in Commercial Distribution
- 00851861007222 ()
- Circumference: 200 Millimeter
- Mandible-repositioning sleep-disordered breathing orthosis
Acessa ProVu Transducer with sensor, Reusable, connects to the Acessa ProVu Console
ACESSA HEALTH INC.
7700
In Commercial Distribution
- 00854763006188 ()
- Surgical ultrasound imaging transducer
Femoral Stem Impactor with Anteversion
TOTAL JOINT ORTHOPEDICS, INC.
1307.00.000
In Commercial Distribution
- 00819251021197 ()
- Orthopaedic implant impactor, reusable
CER-BD-A ASSEMBLY PACK
PN 69011-01M
RANFAC CORP.
CER-BD-A
In Commercial Distribution
- 00850023741639 ()
- Non-fixed blood collection needle
The Accuryn Monitor Mount with Clamp consists of a handle, monitor attachment piece, and clamp with knob. The monitor may be attached to an IV Pole with the pole-clamp and knob.
POTRERO MEDICAL, INC.
FGN-06-100202
In Commercial Distribution
- 00850019755237 ()
FGN-06-100202
- Portable active medical device mount
Mini sheath, 65cm – L2 with FlexCath Cross
ACUTUS MEDICAL, INC.
012852-005
In Commercial Distribution
- 00850027837697 ()
012852-005
- Cardiac transseptal access set
Mobile Touch Dock with battery. Includes Power Cable Holder
Bk Medical ApS
UA1814
Not in Commercial Distribution
- 05704916001087 ()
- General-purpose ultrasound imaging system
Mobile Keyboard Dock with backpack and battery. Includes Power Cable Holder
Bk Medical ApS
UA1214
Not in Commercial Distribution
- 05704916001056 ()
- General-purpose ultrasound imaging system
Product Box also contain OS-SPA DI 00850391007146
ABYRX, INC.
OS-101
In Commercial Distribution
- 00850391007160 ()
- 00850391007139 ()
- Bone wax, synthetic
Product Box also contains OS-SPA DI 00850391007146
ABYRX, INC.
OS-201
In Commercial Distribution
- 00850391007153 ()
- 00850391007023 ()
- Bone wax, synthetic
Seamfree Single Syringe with Tips
Vista Dental
1
In Commercial Distribution
- 00850194007336 ()
104-01
- Dental restorative unfilled resin kit, standard
Siliclone X-Act with 4 Tips Impression Material Proprietary
Westone Laboratories, Inc.
NA
In Commercial Distribution
- 00850047788009 ()
10112
- Earmould impression material
Precision Systems OSMETTE III osmometer with Barcode Reader
Precision Systems, Inc.
5010B
In Commercial Distribution
- 00850041049830 ()
5010B
- Osmometric analyser IVD
Precision Systems OSMETTE XL with Barcode Reader
Precision Systems, Inc.
5007B
In Commercial Distribution
- 00850041049762 ()
5007B
- Osmometric analyser IVD
No Description
Medicomp
MC-4425
In Commercial Distribution
- 10858409005600 ()
- 00858409005603 ()
MC-4425
- Straight/elbow breathing circuit connector, single-use
No Description
Medicomp
MC-6605
In Commercial Distribution
- 10858409005389 ()
- 00858409005382 ()
MC-6605
- Anaesthesia breathing circuit, single-use
The Molar Procedure Instrument with Accessories, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
SONENDO, INC.
FG-001-00025
In Commercial Distribution
- 00858395006332 ()
- 00858395006349 ()
GW-MOL-PI10
- Dental delivery system instrument unit, electric
The Anterior/Premolar Procedure Instrument with Matrix, when used with the GentleWave Console, is intended to be used on the anterior or premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the procedure site.
SONENDO, INC.
FG-003-00011
In Commercial Distribution
- 00858395006318 ()
GW-APM-PI01
- Dental delivery system instrument unit, electric
A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.
BRONCUS MEDICAL INC.
12196-09
In Commercial Distribution
- 00856571007234 ()
10009-09
- Lung biopsy procedure kit
ZipCombo Centrifuge, hematocrit rotor, capacity 12-40mm tubes
LW SCIENTIFIC, INC.
ZCC-12HD-40T3
In Commercial Distribution
- 00664816001745 ()
- Microhaematocrit centrifuge IVD
DermLite Foto X with Nailio
DermLite LLC
DLFX-NL1
In Commercial Distribution
- 00855997006890 ()
DLFX-NL1
- Dermatoscope, optical
PFFG3-32 RA Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-32 RA
In Commercial Distribution
- 10856449006267 ()
- 00856449006260 ()
- 20856449006264 ()
- Catheter Gauge: 32 French
- Pleural catheter
- Mediastinal drainage catheter, non-antimicrobial
- Closed-wound drain, non-bioabsorbable
PFFG3-28 RA Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-28 RA
In Commercial Distribution
- 10856449006250 ()
- 00856449006253 ()
- 20856449006257 ()
- Catheter Gauge: 28 French
- Pleural catheter
- Mediastinal drainage catheter, non-antimicrobial
- Closed-wound drain, non-bioabsorbable
PFFG3-24 RA Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-24 RA
In Commercial Distribution
- 10856449006243 ()
- 00856449006246 ()
- 20856449006240 ()
- Catheter Gauge: 24 French
- Pleural catheter
- Mediastinal drainage catheter, non-antimicrobial
- Closed-wound drain, non-bioabsorbable
PFFG3-24 XDL Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-24 XDL
In Commercial Distribution
- 10856449006236 ()
- 00856449006239 ()
- 20856449006233 ()
- Catheter Gauge: 24 French
- Pleural catheter
- Mediastinal drainage catheter, non-antimicrobial
- Closed-wound drain, non-bioabsorbable
PFFG3-20 XDL Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-20 XDL
In Commercial Distribution
- 10856449006229 ()
- 00856449006222 ()
- 20856449006226 ()
- Catheter Gauge: 20 French
- Pleural catheter
- Mediastinal drainage catheter, non-antimicrobial
- Closed-wound drain, non-bioabsorbable
PFFG3-32 Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-32
In Commercial Distribution
- 10856449006205 ()
- 00856449006208 ()
- 20856449006202 ()
- Catheter Gauge: 32 French
- Pleural catheter
- Mediastinal drainage catheter, non-antimicrobial
- Closed-wound drain, non-bioabsorbable
PFFG3-28 Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-28
In Commercial Distribution
- 10856449006199 ()
- 00856449006192 ()
- 20856449006196 ()
- Catheter Gauge: 28 French
- Pleural catheter
- Mediastinal drainage catheter, non-antimicrobial
- Closed-wound drain, non-bioabsorbable
PFFG3-24 Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-24
In Commercial Distribution
- 10856449006182 ()
- 00856449006185 ()
- 20856449006189 ()
- Catheter Gauge: 24 French
- Pleural catheter
- Mediastinal drainage catheter, non-antimicrobial
- Closed-wound drain, non-bioabsorbable
PFFG3-20 Pleuraflow® System with FlowGlide
Clearflow, Inc.
PFFG3-20
In Commercial Distribution
- 10856449006175 ()
- 00856449006178 ()
- 20856449006172 ()
- Catheter Gauge: 20 French
- Pleural catheter
- Mediastinal drainage catheter, non-antimicrobial
- Closed-wound drain, non-bioabsorbable
PFFG-32 RA PleuraFlow® System with FlowGlide™
Clearflow, Inc.
PFFG-32 RA
In Commercial Distribution
- 00856449006147 ()
- 10856449006144 ()
- 20856449006141 ()
- Catheter Gauge: 32 French
- Mediastinal drainage catheter, non-antimicrobial
- Pleural catheter
- Closed-wound drain, non-bioabsorbable
PFFG-28 RA PleuraFlow® System with FlowGlide
Clearflow, Inc.
PFFG-28 RA
In Commercial Distribution
- 20856449006127 ()
- 10856449006120 ()
- 00856449006123 ()
- Catheter Gauge: 28 French
- Closed-wound drain, non-bioabsorbable
- Mediastinal drainage catheter, non-antimicrobial
- Pleural catheter
PFFG-24 RA PleuraFlow® System with FlowGlide
Clearflow, Inc.
PFFG-24 RA
In Commercial Distribution
- 20856449006110 ()
- 10856449006113 ()
- 00856449006116 ()
- Catheter Gauge: 24 French
- Closed-wound drain, non-bioabsorbable
- Pleural catheter
- Mediastinal drainage catheter, non-antimicrobial
PFFG-24 XDL PleuraFlow® System with FlowGlide
Clearflow, Inc.
PFFG-24 XDL
In Commercial Distribution
- 20856449006103 ()
- 10856449006106 ()
- 00856449006109 ()
- Catheter Gauge: 24 French
- Pleural catheter
- Mediastinal drainage catheter, non-antimicrobial
- Closed-wound drain, non-bioabsorbable