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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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Heartprint medical model, SLS
Materialise NV
HEAPR-01-001-01
In Commercial Distribution

  • 05420060346019 ()
HEAPR-01-001-01

  • Custom-made organ/bone anatomy model
Heartprint medical model, SLA
Materialise NV
HEAPR-01-002-01
In Commercial Distribution

  • 05420060346002 ()
HEAPR-01-002-01

  • Custom-made organ/bone anatomy model
Lower extremity Guide and Model
Materialise NV
O-01-0-300000-0021-020
In Commercial Distribution

  • 05420060343407 ()
O-01-0-300000-0021-020

  • Custom-made organ/bone anatomy model/surgical guide kit
KNEE TOTAL PACK
MEDLINE INDUSTRIES, INC.
DYNJ04383G
In Commercial Distribution

  • 10889942200054 ()
DYNJ04383G

  • General surgical procedure kit, non-medicated, single-use
MINOR LITHOTOMY PACK
MEDLINE INDUSTRIES, INC.
DYNJ04382F
In Commercial Distribution

  • 10889942200047 ()
DYNJ04382F

  • General surgical procedure kit, non-medicated, single-use
C-SECTION PACK-LF
MEDLINE INDUSTRIES, INC.
CDS830200J
In Commercial Distribution

  • 10889942200016 ()
CDS830200J

  • General surgical procedure kit, medicated
CARDIAC CATH PACK - NO ANGIO
MEDLINE INDUSTRIES, INC.
DYNJ30268B
In Commercial Distribution

  • 10889942199983 ()
DYNJ30268B

  • General surgical procedure kit, non-medicated, reusable
ARTHROSCOPY PACK
MEDLINE INDUSTRIES, INC.
DYNJ04874I
In Commercial Distribution

  • 10889942199969 ()
DYNJ04874I

  • General surgical procedure kit, non-medicated, reusable
OPEN HEART ACCESSORY PACK
MEDLINE INDUSTRIES, INC.
DYNJ04777C
In Commercial Distribution

  • 10889942199952 ()
DYNJ04777C

  • General surgical procedure kit, non-medicated, reusable
MOR LAP
MEDLINE INDUSTRIES, INC.
DYNJ902844
In Commercial Distribution

  • 40889942199922 ()
  • 10889942199921 ()
DYNJ902844

  • General surgical procedure kit, non-medicated, reusable
MOR GYN
MEDLINE INDUSTRIES, INC.
DYNJ902845
In Commercial Distribution

  • 40889942199915 ()
  • 10889942199914 ()
DYNJ902845

  • General surgical procedure kit, non-medicated, reusable
MOR BASIC PROCEDURE
MEDLINE INDUSTRIES, INC.
DYNJ902846
In Commercial Distribution

  • 10889942199907 ()
DYNJ902846

  • General surgical procedure kit, non-medicated, reusable
MOR LAPAROSCOPY
MEDLINE INDUSTRIES, INC.
DYNJ902843
In Commercial Distribution

  • 40889942199892 ()
  • 10889942199891 ()
DYNJ902843

  • General surgical procedure kit, non-medicated, reusable
MAJOR PACK
MEDLINE INDUSTRIES, INC.
DYNJ04379I
In Commercial Distribution

  • 10889942199877 ()
DYNJ04379I

  • General surgical procedure kit, non-medicated, single-use
LAMINECTOMY PACK
MEDLINE INDUSTRIES, INC.
DYNJ04376I
In Commercial Distribution

  • 10889942199860 ()
DYNJ04376I

  • General surgical procedure kit, non-medicated, single-use
HIP TOTAL PACK
MEDLINE INDUSTRIES, INC.
CDS941038G
In Commercial Distribution

  • 10889942199846 ()
  • 40889942199847 ()
CDS941038G

  • General surgical procedure kit, non-medicated, single-use
AAA/AFB PACK
MEDLINE INDUSTRIES, INC.
DYNJ04771L
In Commercial Distribution

  • 10889942199761 ()
DYNJ04771L

  • General surgical procedure kit, non-medicated, reusable
MOR ORTHO MINOR
MEDLINE INDUSTRIES, INC.
DYNJ902842
In Commercial Distribution

  • 40889942199755 ()
  • 10889942199754 ()
DYNJ902842

  • General surgical procedure kit, non-medicated, reusable
MAJOR LITHOTOMY PACK
MEDLINE INDUSTRIES, INC.
DYNJ04541K
In Commercial Distribution

  • 10889942199747 ()
  • 40889942199748 ()
DYNJ04541K

  • General surgical procedure kit, non-medicated, single-use
LAPAROSCOPIC GYN PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ04533K
In Commercial Distribution

  • 10889942199730 ()
DYNJ04533K

  • General surgical procedure kit, non-medicated, single-use
CYSTOSCOPY PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ04531G
In Commercial Distribution

  • 10889942199723 ()
DYNJ04531G

  • General surgical procedure kit, non-medicated, single-use
CYSTOSCOPY PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ04545G
In Commercial Distribution

  • 10889942199709 ()
DYNJ04545G

  • General surgical procedure kit, non-medicated, single-use
OPEN SHOULDER PACK
MEDLINE INDUSTRIES, INC.
DYNJ04544G
In Commercial Distribution

  • 10889942199693 ()
DYNJ04544G

  • General surgical procedure kit, non-medicated, single-use
LAP CHOLE PACK
MEDLINE INDUSTRIES, INC.
DYNJ04538J
In Commercial Distribution

  • 10889942199686 ()
DYNJ04538J

  • General surgical procedure kit, non-medicated, single-use
TRULIFE ZENITH LP FOOT 25CM LEFT CAT 2
TRULIFE LIMITED
SZN100-25-L-2
In Commercial Distribution

  • 00645517881942 ()


  • Mechanical-resistance external ankle-foot prosthesis
TRULIFE ZENITH LP FOOT 25CM LEFT CAT 1
TRULIFE LIMITED
SZN100-25-L-1
In Commercial Distribution

  • 00645517881935 ()


  • Mechanical-resistance external ankle-foot prosthesis
TRULIFE ZENITH LP FOOT 24CM RIGHT CAT 3
TRULIFE LIMITED
SZN100-24-R-3
In Commercial Distribution

  • 00645517881928 ()


  • Mechanical-resistance external ankle-foot prosthesis
TRULIFE ZENITH LP FOOT 24CM RIGHT CAT 2
TRULIFE LIMITED
SZN100-24-R-2
In Commercial Distribution

  • 00645517881911 ()


  • Mechanical-resistance external ankle-foot prosthesis
TRULIFE ZENITH LP FOOT 24CM RIGHT CAT 1
TRULIFE LIMITED
SZN100-24-R-1
In Commercial Distribution

  • 00645517881904 ()


  • Mechanical-resistance external ankle-foot prosthesis
TRULIFE ZENITH LP FOOT 24CM LEFT CAT 3
TRULIFE LIMITED
SZN100-24-L-3
In Commercial Distribution

  • 00645517881898 ()


  • Mechanical-resistance external ankle-foot prosthesis
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