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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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PG&E Wilderness Tactical - Trauma Bag - 00766588233178

PG&E Wilderness Tactical - Trauma Bag
Certified Safety Manufacturing, Inc.
K623-317
In Commercial Distribution

  • 00766588233178 ()
K623-317

  • First aid kit, medicated

36M - PG&E Class B 21 - 00766588233055

36M - PG&E Class B 21
Certified Safety Manufacturing, Inc.
K623-305
In Commercial Distribution

  • 00766588233055 ()
K623-305

  • First aid kit, medicated

16PW - PG&E Class A 21 - 00766588233048

16PW - PG&E Class A 21
Certified Safety Manufacturing, Inc.
K623-304
In Commercial Distribution

  • 00766588233048 ()
K623-304

  • First aid kit, medicated

Endo-Express - 00766054001201

Endo-Express E Type 4-Hole Air Motor
ESSENTIAL DENTAL SYSTEMS, INC.
5510-00
Not in Commercial Distribution

  • 00766054001201 ()
5510-00

  • Dental power tool handpiece motorless component

Newport - 10884521541047

e360 Ventilator with Accessories;E Model
Covidien LP
E360P-SY-NA
Not in Commercial Distribution

  • 10884521541047 ()
E360P-SY-NA

  • Neonatal/adult intensive-care ventilator

T2Bacteria® QCheck Negative Kit - M70885080743

Negative Control for T2Bacteria Panel
T2 BIOSYSTEMS, INC.
85-08074
In Commercial Distribution

  • M70885080743 ()
  • M70883080760 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

T2Bacteria® QCheck Positive Kit - M70885080730

Positive ASK Control, Positive EPE Control
T2 BIOSYSTEMS, INC.
85-08073
In Commercial Distribution

  • M70885080730 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

T2Bacteria® QCheck Positive Kit - M70885071910

Positive SK Control, Positive EPE Control
T2 BIOSYSTEMS, INC.
85-07191
In Commercial Distribution

  • M70885071910 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control

VIVIT Supply - 10810141931401

Commend Nitrile Exam Glove, Chemo Drug Tested, Textured Fingertips, Powder-Free,
Vivit Supply LLC
20121
In Commercial Distribution

  • 20810141931408 ()
  • 10810141931401 ()
  • 00810141931404 ()


  • Total immunoglobulin E (IgE total) IVD, kit, rapid ICT, clinical

Thermoflect - 00612899004184

THERMOFLECT GOWN KIT E, 25 EA TS THERMOFLECT GOWN KIT E, GOWN, CAP, 25 EA NONWOVEN
Encompass Group, L.L.C.
5000-840
In Commercial Distribution

  • 10612899004181 ()
  • 00612899004184 ()


  • Hypothermia-prevention whole-body suit
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