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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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i-ROOT 100 - 08809455600641

FILE HOLDER A FOR IROOT 100
META SYSTEMS CO., LTD.
iRB-008
Not in Commercial Distribution

  • 08809455600641 ()


  • Endodontic apex locator

i-ROOT 100 - 08809455600634

i-ROOT 100
META SYSTEMS CO., LTD.
iRB-003
Not in Commercial Distribution

  • 08809455600634 ()


  • Endodontic apex locator

Derma-R Cream - 00382098010506

Derma-R Cream is a non-sterile formulation intended for topical application. It is intended for management of pruritus and Dryness of skin in Atopic dermatitis and Allergic contact dermatitis. Not to be used on Breached or Compromised skin or open sores.
Raya Pharmaceuticals LLC
1
In Commercial Distribution

  • 00382098010506 ()


  • Dry skin moisture barrier dressing

Neosalus Lotion - 00381811000022

NEOSALUS Lotion is a fragrance-free, water-soluble dressing formulated for the management and relief of irritation experienced with various types of dermatoses including atopic dermatitis and allergic contact dermatitis. NEOSALUS Lotion is intended for topical application.
Resilia Pharmaceuticals, Inc.
1
In Commercial Distribution

  • 00381811000022 ()

  • Weight: 226.7 Gram


  • Dry skin moisture barrier dressing

Neosalus Cream - 00381811000008

NEOSALUS Cream is a fragrance-free, water-soluble dressing formulated for the management of various types of dermatoses including atopic dermatitis and allergic contact dermatitis. NEOSALUS Cream is intended for topical application.
Resilia Pharmaceuticals, Inc.
1
In Commercial Distribution

  • 00381811000008 ()

  • Weight: 100 Gram


  • Dry skin moisture barrier dressing

ABBOTT - 00380740011635

XSYSTEMS TDx/TDx Flx Methotrexate II Reagent Pack
ABBOTT LABORATORIES
7A12-60
Not in Commercial Distribution

  • 00380740011635 ()
07A1260

  • Methotrexate therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

ABBOTT - 00380740011628

XSYSTEMS TDx/TDx Flx Methotrexate II Controls
ABBOTT LABORATORIES
7A12-10
Not in Commercial Distribution

  • 00380740011628 ()
07A1210

  • Methotrexate therapeutic drug monitoring IVD, control

ABBOTT - 00380740011611

XSYSTEMS TDx/TDx Flx Methotrexate II Calibrators
ABBOTT LABORATORIES
7A12-01
Not in Commercial Distribution

  • 00380740011611 ()
07A1201

  • Methotrexate therapeutic drug monitoring IVD, calibrator

ARCHITECT - 00380740011529

Phencyclidine
ABBOTT LABORATORIES
6L96-20
In Commercial Distribution

  • 00380740011529 ()
06L9620

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)

N/A - 00382903401833

HLA-B27 Kit Tests IVD
Becton, Dickinson And Company
340183
In Commercial Distribution

  • 00382903401833 ()
340183

  • White blood cell count IVD, kit, cell count
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