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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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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
Integrity One Piece, threaded Abutment for 6.0-8.0mm implants
Suncoast Dental, Inc
PITI-OP 6.0-8.0 (0°)
In Commercial Distribution

  • 00083208967801 ()

  • Angle: 0 degree
  • Height: 7.0 Millimeter
PITI-OP 6.0-8.0 (0°)

  • Dental implant suprastructure, permanent, preformed
Integrity One Piece, threaded Abutment for 5.0mm implants
Suncoast Dental, Inc
PITI-OP 5.0 (0°)
In Commercial Distribution

  • 00083208950070 ()

  • Angle: 0 degree
  • Height: 7.0 Millimeter
PITI-OP 5.0 (0°)

  • Dental implant suprastructure, permanent, preformed
Integrity Implant Abutment 5.0mm x 0 degree -7mm Height
Suncoast Dental, Inc
Abutment 5.0mm x 0 degree (Straight) Integrity Post
In Commercial Distribution

  • 00083208950001 ()

  • Outer Diameter: 5 Millimeter
  • Integrity Implant Abutment (Post) 5.0mm Diameter x 0°(Degree) Angle x 7mm Height
  • Height: 7 Millimeter
PITI 5.0 (0°)

  • Dental implant suprastructure, permanent, preformed
Integrity One Piece, Threaded Abutment for 3.7-4.5mm implants
Suncoast Dental, Inc
PITI-OP 3.7-4.5 (0°)
In Commercial Distribution

  • 00083208934452 ()

  • Height: 7.0 Millimeter
  • Angle: 0 degree
PITI-OP 3.7-4.5 (0°)

  • Dental implant suprastructure, permanent, preformed
Integrity Implant Abutment 3.7 - 4.5mm x 0° (Straight) -7mm Height. To fit Integrity Implants diameter sizes 3.7 to 4.5 mm.
Suncoast Dental, Inc
Abutment 3.7 - 4.5mm x 0° (Straight) Integrity Post
In Commercial Distribution

  • 00083208903458 ()

  • Height: 7 Millimeter
  • Outer Diameter: 3.2 Millimeter
  • Integrity Implant Abutment (Post) 3.7 - 4.5mm Diameter x 0°(Straight) x 7mm Height
PITI-3.7 - 4.5 (0°)

  • Dental implant suprastructure, permanent, preformed
PITI 6.0-8.0 (0°) Degree Platform Switch Post, 7mm tall for ITI 6.0-8.0 Implants
Suncoast Dental, Inc
PITI 6.0-8.0 (0°) Degree Platform Switch Post, 7mm tall for ITI 6.0-8.0 Implants
In Commercial Distribution

  • 00083208600067 ()

  • Outer Diameter: 6 Millimeter
  • Height: 7 Millimeter
  • PITI 6.0-8.0 (0°) Degree Platform Switch Post, 7mm tall for ITI 6.0-8.0 Implants
PITI 6.0-8.0 (0°)

  • Dental implant suprastructure, permanent, preformed
UV - Tanning lamp, Accession # 102 0131-000 <CR> Exclusive distributor for USA: JW North America, Inc., 233 Libbey Industrial Pkwy, Unit 2, Weymouth, MA 02189, Phone: +1 781 331 0949, Email: kapgar@jwnorthamerica.com <CR> Manufacturer: NARVA Lichtquellen GmbH + Co. KG, Industriegebiet Nord, Erzstrasse 22, 09618 Brand-Erbisdorf, Germany, Phone: +49 37322 17 200, Email: office@narva-bel.de, http://www.narva-bel.de
NARVA Lichtquellen GmbH + Co KG.
FR59 T12 80W PH / BiPin
Not in Commercial Distribution

  • 84014501003387 ()
  • 54014501503381 ()
  • 04014501003381 ()
9865 7174 0

  • Ultraviolet tanning device
UV - Tanning lamp, Accession # 092 0263-000 <CR> Exclusive distributor for USA: JW North America, Inc., 233 Libbey Industrial Pkwy, Unit 2, Weymouth, MA 02189, Phone: +1 781 331 0949, Email: kapgar@jwnorthamerica.com <CR> Manufacturer: NARVA Lichtquellen GmbH + Co. KG, Industriegebiet Nord, Erzstrasse 22, 09618 Brand-Erbisdorf, Germany, Phone: +49 37322 17 200, Email: office@narva-bel.de, http://www.narva-bel.de
NARVA Lichtquellen GmbH + Co KG.
F73 T12 100W RS / RDC
Not in Commercial Distribution

  • 84014501003370 ()
  • 54014501503374 ()
  • 04014501003374 ()
9865 6874 0

  • Ultraviolet tanning device
No Description
STRYKER SUSTAINABILITY SOLUTIONS, INC.
M004 RARC01 0
In Commercial Distribution

  • 07613327515800 ()

  • Length: 6.6 Feet
M004 RARC01 0

  • Electrical-only medical device connection cable, reprocessed
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