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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Non-sterile, non-implantable wound dressing
Keranetics, Inc.
00
In Commercial Distribution

  • B789P00211 ()
  • B789P00210 ()

  • Total Volume: 5 Milliliter


  • Skin semi-occlusive dressing, non-antimicrobial
Sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing
Keranetics, Inc.
00
In Commercial Distribution

  • B789P00100 ()
  • B789P00101 ()

  • Total Volume: 5 Milliliter


  • Wound hydrogel dressing, non-antimicrobial
Prevahex Antimicrobial Transparent Film Dressings, I.V. Securement, 3.8 IN x 4.6 IN, 100 Dressings/Case, 1492CH
Entrotech Life Sciences, LLC
1492BOX
In Commercial Distribution

  • B5591492CASE3 ()
  • B5591492BOX1 ()
  • B5591492CH0 ()
1492BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, I.V. Securement, 2.8 IN x 3.5 IN, 100 Dressings/Case, 1491CH
Entrotech Life Sciences, LLC
1491BOX
In Commercial Distribution

  • B5591491CH0 ()
  • B5591491BOX1 ()
  • B5591491CASE3 ()
1491BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, I.V. Securement, 2.8 IN Diameter, 400 Dressings/Case, 1488CH
Entrotech Life Sciences, LLC
1488BOX
Not in Commercial Distribution

  • B5591488BOX1 ()
  • B5591488CH0 ()
  • B5591488CASE3 ()
1488BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, Frame Style, 4 IN x 4.75 IN, 200 Dressings/Case, 1485CH
Entrotech Life Sciences, LLC
1485BOX
In Commercial Distribution

  • B5591485BOX1 ()
  • B5591485CH0 ()
  • B5591485CASE3 ()
1485BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, Frame Style, 2.375 IN x 2.75 IN, 400 Dressings/Case, 1484CH
Entrotech Life Sciences, LLC
1484BOX
In Commercial Distribution

  • B5591484BOX1 ()
  • B5591484CH0 ()
  • B5591484CASE3 ()
1484BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, Frame Style, 1.75 IN x 1.75 IN, 400 Dressings/Case, 1483CH
Entrotech Life Sciences, LLC
1483BOX
In Commercial Distribution

  • B5591483BOX1 ()
  • B5591483CH0 ()
  • B5591483CASE3 ()
1483BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
The Compartmental Compressibility Monitoring System (CPMX1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility. The CPMX1 System includes the CP Probe, a handheld and reusable probe combining a flat linear ultrasound array with an integrated pressure sensor to obtain cross-section ultrasound views of the compartment of interest. The CP Probe works in conjunction with the CPMX1 Software, which provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure. Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value.
Compremium AG
1
In Commercial Distribution

  • G247CPMX10 ()
  • G247CPMX12 ()


  • Compartmental-pressure monitoring system, reusable
Immunoassay for the detection of PCP in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7022
In Commercial Distribution

  • M90107RD70221 ()
  • M90107RD70220 ()

  • Length: 75 Millimeter
07RD7022

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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