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No Description
STEINER BIOTECHNOLOGY LLC.
SteinerBio Socket Graft 1.0 cc
In Commercial Distribution
- 00860010170113 ()
- Synthetic bone graft
No Description
STEINER BIOTECHNOLOGY LLC.
SteinerBio Socket Graft 0.5 cc
In Commercial Distribution
- 00860010170106 ()
- Synthetic bone graft
The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps.
The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time
Iterative Scopes, Inc.
SKOUT210
In Commercial Distribution
- 00860010168417 ()
- Endoscopic video image interpretive unit
The SKOUT System is a medical device designed to assist endoscopists performing colonoscopies with the real-time detection of potential colorectal polyps.
The SKOUT system integrates directly into the clinical workflow for colonoscopy procedures. Once installed, the SKOUT system provides the user with the ability to switch between two different feeds, the bypass endoscopic feed, and the SKOUT feed, using the mode selection button. When the SKOUT feed is selected, the user will be able to perform a colonoscopy procedure with the SKOUT system processing and detecting potential polyps in real time.
Iterative Scopes, Inc.
SKOUT200
In Commercial Distribution
- 00860010168400 ()
- Endoscopic video image interpretive unit
Electronic stethoscope
CHESTPAL LTD
LUS110
In Commercial Distribution
- 00860010159415 ()
- 00860010159408 ()
- Electronic acoustic stethoscope
The all.health Algo SaMD™ Model 1000 oximeter is a pulse oximeter configured to operate in Software as a Medical Device (“SaMD”). The software device is intended to run remotely as an optional cloud service component of a complete all.health ICM™ system, a non-medical-device clinical decision support system.
The software device collects input from compatible remote hardware sensor bands or other sensors, then filters, analyzes, and validates the collected data to produce a clinical-grade pulse measurement of heart rate (HRp), respiration rate (RRp), and blood oxygenation (SpO2%) for output, including outlier rejection, averages, trends, and ranges over time for the purpose of remote patient monitoring.
Medical Device Info.
• Class II (enforcement discretion) medical device
• Regulation: Oximeter, 870.2700
• Rx. Federal law (USA) restricts this product to sale by or on the order of a licensed practitioner.
All.health, Inc.
Model 1000
In Commercial Distribution
- 00860010157008 ()
ALGO-m1000-SW (rev 0)
- Pulse oximeter
RightEye Vision System™ tracks the amplitude and velocity of rapid, involuntary, and oscillatory ocular movements, measuring changes with eye movement. The system records, analyses, and reports eye movements in real-time.
Righteye, LLC
Tobii Dynavox i15
In Commercial Distribution
- 00860010031902 ()
- Vision physiology/eye movement analysis system
Insulin Pen Needle 4mm length and 32 gauge
Curative Diagnostics
CD-32G4
In Commercial Distribution
- 10860010015237 ()
- 00860010015230 ()
- 20860010015234 ()
- Needle Gauge: 32 Gauge
- Length: 4 Millimeter
60010-0015-23
- Autoinjector needle
Insulin Pen Needle 8mm length and 31 gauge
Curative Diagnostics
CD-31G8
In Commercial Distribution
- 10860010015220 ()
- 00860010015223 ()
- 20860010015227 ()
- Needle Gauge: 31 Gauge
- Length: 8 Millimeter
60010-0015-22
- Autoinjector needle
Insulin Pen Needle 5mm length and 31 gauge
Curative Diagnostics
CD-31G5
In Commercial Distribution
- 10860010015213 ()
- 00860010015216 ()
- 20860010015210 ()
- Needle Gauge: 31 Gauge
- Length: 5 Millimeter
60010-0015-21
- Autoinjector needle