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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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BT37 Benchtop Incubator
PLANER LIMITED
GDBT37-WW-ORIGIO
In Commercial Distribution

  • B199GDBT37WWORIGIO0 ()


  • Assisted reproduction heater/incubator
BT37 Benchtop Incubator.
PLANER LIMITED
GDBT37-US-ORIGIO
In Commercial Distribution

  • B199GDBT37USORIGIO0 ()


  • Assisted reproduction heater/incubator
BT37 Benchtop Incubator - Origio
PLANER LIMITED
GDBT37-01-ORIGIO
In Commercial Distribution

  • B199GDBT3701ORIGIO0 ()


  • Assisted reproduction heater/incubator
L3L DAMON 3 .022 0/+5/0 HK
ORMCO CORPORATION
491-5431
In Commercial Distribution

  • 00889989052749 ()
  • 10889989052746 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, plastic, single-use
L3R DAMON 3 .022 0/+5/0 HK
ORMCO CORPORATION
491-5430
In Commercial Distribution

  • 00889989052732 ()
  • 10889989052739 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, plastic, single-use
U3L DAMON 3 .022 0/+6/0 HK
ORMCO CORPORATION
491-5331
In Commercial Distribution

  • 00889989052701 ()
  • 10889989052708 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, plastic, single-use
U3R DAMON 3 .022 0/+6/0 HK
ORMCO CORPORATION
491-5330
In Commercial Distribution

  • 00889989052695 ()
  • 10889989052692 ()

  • Slot Width: .022 Inch


  • Orthodontic bracket, plastic, single-use
R3 SCREW-IN TRIAL LINER +4MM 0¿0/58
Smith & Nephew, Inc.
E0015861-1
In Commercial Distribution

  • 00885556713242 ()
E0015861-1

  • Acetabulum prosthesis trial, prefabricated, reusable
R3 SCREW-IN TRIAL LINER +4MM 0¿0/56
Smith & Nephew, Inc.
E0015793-1
In Commercial Distribution

  • 00885556709597 ()
E0015793-1

  • Acetabulum prosthesis trial, prefabricated, reusable
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
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