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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No Description
ASHLAND SPECIALTY INGREDIENTS G.P.
EBT4 Reflexion Film V2 @20SH
In Commercial Distribution

  • 00810106410852 ()
989194

  • Medical x-ray film, non-screen
Gafchromic Films
ASHLAND SPECIALTY INGREDIENTS G.P.
EBT3 Reflexion Film V2 @20SH
In Commercial Distribution

  • 00810106410395 ()
982341

  • Medical x-ray film, non-screen
Sterile needle guide with (14 x 61cm) flat-folded CIV-Flex™ cover for use with Siemens 4V2, V4, V2, L5, L7, C3, C366, C5, C544, 8L5, 6L3 and 5C2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
612-068
In Commercial Distribution

  • 00841436104838 ()
  • 10841436104835 ()

  • Width: 1.8 Inch
  • Length: 4.8 Inch
612-068

  • Needle guide, single-use
No Description
Roche Molecular Systems, Inc.
09048634190
In Commercial Distribution

  • 00875197006285 ()
09048634190

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9050
Not in Commercial Distribution

  • 08806387890508 ()


  • Endodontic obturation system
The Revian 2M USB to Magnetic Cable & Insert v2 Replacement Kit is a kit that may be shipped to users of the REVIAN Red device (Catalog # 10001) who have lost or misplaced their Magnetic Micro-USB Connector or Magnetic Cable originally supplied with the REVIAN Red Device.
Revian, Inc.
10000-12722
In Commercial Distribution

  • 00850003374130 ()
12722

  • Hair growth laser device
No Description
MICROSURGICAL TECHNOLOGY, INC.
Ti-98432
In Commercial Distribution

  • 00844685004096 ()
Ti-98432

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
No Description
MICROSURGICAL TECHNOLOGY, INC.
Ti-98431
In Commercial Distribution

  • 00844685004089 ()
Ti-98431

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
No Description
Natus Medical Denmark ApS
1085, FACE PAD ASSEMBLY KIT V2
In Commercial Distribution

  • 05713315008467 ()
  • 05713315008504 ()
  • 05713315008498 ()
8-35-39300

  • Electronystagmograph
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS PAD SET SAND V2
In Commercial Distribution

  • 00045915829698 ()
100-GRAVIS-019

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS PAD SET SADDLE V2
In Commercial Distribution

  • 00045915829681 ()
100-GRAVIS-018

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS PAD SET GRAY V2
In Commercial Distribution

  • 00045915829629 ()
100-GRAVIS-017

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS PAD SET BLACK V2
In Commercial Distribution

  • 00045915829612 ()
100-GRAVIS-016

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS PAD SET BONE V2
In Commercial Distribution

  • 00045915829605 ()
100-GRAVIS-020

  • Bed/chair electric massager
COPPER PLUS LEVEL 2
UTAK LABORATORIES, INC.
COP+ 2 V2 S F UW
In Commercial Distribution

  • B800COP2V2SFUW5 ()
  • B800COP2V2SFUW0 ()

  • Total Volume: 5 Milliliter
COP+ 2 V2 S F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
COPPER PLUS LEVEL 1
UTAK LABORATORIES, INC.
COP+ 1 V2 S F UW
In Commercial Distribution

  • B800COP1V2SFUW5 ()
  • B800COP1V2SFUW0 ()

  • Total Volume: 5 Milliliter
COP+ 1 V2 S F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
CODEINE GLUCURONIDE PLUS LEVEL 1
UTAK LABORATORIES, INC.
COD GLUC+ 1 V2 U PM
In Commercial Distribution

  • B800CODGLUC1V2UPM5 ()
  • B800CODGLUC1V2UPM0 ()

  • Total Volume: 3 Milliliter
COD GLUC+ 1 V2 U PM

  • Multiple-type clinical chemistry analyte profile IVD, control
CCDKMQC2V2WBUK
UTAK LABORATORIES, INC.
CCDKM QC 2 V2 WB UK
In Commercial Distribution

  • B800CCDKMQC2V2WBUK5 ()
  • B800CCDKMQC2V2WBUK0 ()

  • Total Volume: 3 Milliliter
CCDKM QC 2 V2 WB UK

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE POSITIVE
UTAK LABORATORIES, INC.
DA POS V2 WB F KBI
In Commercial Distribution

  • B800DAPOSV2WBFKBI5 ()
  • B800DAPOSV2WBFKBI0 ()

  • Total Volume: 3 Milliliter
DA POS V2 WB F KBI

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LOW
UTAK LABORATORIES, INC.
DA LOW V2 WB F BTL
In Commercial Distribution

  • B800DALOWV2WBFBTL5 ()
  • B800DALOWV2WBFBTL0 ()

  • Total Volume: 1 Milliliter
DA LOW V2 WB F BTL

  • Multiple drugs of abuse IVD, control
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