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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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rexpander - D894BE050

rexpander 2.0 x 9
Rex Implants, Inc.
2.0 x 9
In Commercial Distribution

  • D894BE050 ()

  • Height: 9 Millimeter
  • Width: 2.0 Millimeter
BE-05

  • Maxillofacial bone separator

rexpander - D894BE040

rexpander 1.6 x 15
Rex Implants, Inc.
1.6 x 15
In Commercial Distribution

  • D894BE040 ()

  • Height: 15 Millimeter
  • Width: 1.6 Millimeter
BE-04

  • Maxillofacial bone separator

rexpander - D894BE030

rexpander 1.6 x 13
Rex Implants, Inc.
1.6 x 13
In Commercial Distribution

  • D894BE030 ()

  • Height: 13 Millimeter
  • Width: 1.6 Millimeter
BE-03

  • Maxillofacial bone separator

rexpander - D894BE020

rexpander 1.6 x 11
Rex Implants, Inc.
1.6 x 11
In Commercial Distribution

  • D894BE020 ()

  • Height: 11 Millimeter
  • Width: 1.6 Millimeter
BE-02

  • Maxillofacial bone separator

rexpander - D894BE010

rexpander 1.6 x 9
Rex Implants, Inc.
1.6 x 9
In Commercial Distribution

  • D894BE010 ()

  • Width: 1.6 Millimeter
  • Height: 9 Millimeter
BE-01

  • Maxillofacial bone separator

iSage Rx - 00850006610006

iSage Rx™ (iSage Rx Basal Insulin Titration)
Amalgam Rx Inc
Version 2.X
In Commercial Distribution

  • 00850006610006 ()


  • Home pharmaceutical management support software

Signia - 05714880213157

ACC. STYLETTO X CHARGER-C
Ws Audiology Usa, Inc.
Styletto X Charger
In Commercial Distribution

  • 05714880213157 ()
21030562

  • Air-conduction hearing aid, receiver-in-canal

Tergazyme - 00660483130597

Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
.5 x 500
In Commercial Distribution

  • 00660483130597 ()
1305

  • Medical device cleaning agent

EMAS (Eko Murmur Analysis Software) - 00850010298184

The Eko Murmur Analysis Software is intended to provide decision support to clinicians in their evaluation of patients’ heart sounds. The software analyzes heart sounds and phonocardiograms (and ECG signals, when available). The software will automatically detect murmurs that may be present, and the murmur timing and character, including S1, S2, innocent heart murmurs, structural heart murmurs, and the absence of a heart murmur.
Eko Devices, Inc.
Version 1.x
In Commercial Distribution

  • 00850010298184 ()
EMAS

  • Cardiopulmonary physiological parameter analysis software

Patient Armor Sterilization Pouches - 00858653006005

Patient Armor Sterilization Pouches 2.75 x 10" - 200/Bx
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
2.75" x 10"
In Commercial Distribution

  • 00858653006005 ()
AMH-210

  • Sterilization packaging, single-use
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