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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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INVADER - 15420045506718

No Description
Hologic, Inc.
INVADER MTHFR 677, 1680 TESTS
Not in Commercial Distribution

  • 15420045506718 ()
95-458

  • Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD, kit, nucleic acid technique (NAT)

INVADER - 15420045506688

No Description
Hologic, Inc.
INVADER MTHFR 1298, 144 TESTS
Not in Commercial Distribution

  • 15420045506688 ()
95-455

  • Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD, kit, nucleic acid technique (NAT)

INVADER - 15420045506671

No Description
Hologic, Inc.
INVADER MTHFR 677, 144 TESTS
Not in Commercial Distribution

  • 15420045506671 ()
95-454

  • Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD, kit, nucleic acid technique (NAT)

AMC - 00849593013796

Cable,ECG,Shielded,3 Lead,AAMI,DS com, 10'
Advantage Medical Electronics, LLC
CB-73340R
In Commercial Distribution

  • 00849593013796 ()


  • Electrical-only medical device connection cable, reusable

MEDI - 00636257002575

***DISC*JUXTALITE HD 28 CM LL (M) W/ COM
MEDI MANUFACTURING, INC.
33024017
Not in Commercial Distribution

  • 00636257002575 ()


  • Compression bandaging kit

MEDI - 00636257002544

***DISC*JUXTALITE HD 33 CM LL (XL) W COM
MEDI MANUFACTURING, INC.
33036017
Not in Commercial Distribution

  • 00636257002544 ()


  • Compression bandaging kit

MEDI - 00636257002520

***DISC*JUXTALITE HD 33 CM LL (L) W/ COM
MEDI MANUFACTURING, INC.
33035017
Not in Commercial Distribution

  • 00636257002520 ()


  • Compression bandaging kit

MEDI - 00636257002506

***DISC*JUXTALITE HD 33 CM LL (M) W/ COM
MEDI MANUFACTURING, INC.
33034017
Not in Commercial Distribution

  • 00636257002506 ()


  • Compression bandaging kit

MEDI - 00636257002490

***DISC*JUXTALITE HD 33 CM LL (S) W/ COM
MEDI MANUFACTURING, INC.
33033017
Not in Commercial Distribution

  • 00636257002490 ()


  • Compression bandaging kit

MEDI - 00636257002469

***DISC*JUXTALITE HD 28 CM LL (XL) W COM
MEDI MANUFACTURING, INC.
33026017
Not in Commercial Distribution

  • 00636257002469 ()


  • Compression bandaging kit

MEDI - 00636257002445

***DISC*JUXTALITE HD 28 CM LL (L) W/ COM
MEDI MANUFACTURING, INC.
33025017
Not in Commercial Distribution

  • 00636257002445 ()


  • Compression bandaging kit

MEDI - 00636257002421

***DISC*JUXTALITE HD 28 CM LL (S) W/ COM
MEDI MANUFACTURING, INC.
33023017
Not in Commercial Distribution

  • 00636257002421 ()


  • Compression bandaging kit

MASEL Buccal Tubes - 00190707102791

BT 022 ROTH COM CV GING UR DB (10)
ORTHO ORGANIZERS, INC.
4016-362-10
In Commercial Distribution

  • 00190707102791 ()


  • Orthodontic tube

MASEL Buccal Tubes - 00190707102784

BT 018 ROTH COM CV GING UL DB (10)
ORTHO ORGANIZERS, INC.
4016-361-10
In Commercial Distribution

  • 00190707102784 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087562

.022 UL6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-263-10
In Commercial Distribution

  • 00190707087562 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087555

.022 UR6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-262-10
In Commercial Distribution

  • 00190707087555 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087548

.018 UL6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-261-10
In Commercial Distribution

  • 00190707087548 ()


  • Orthodontic tube

Buccal Tubes Weldable - 00190707087531

.018 UR6 Conv Com Buccal Tube Roth Ging Weldable
ORTHO ORGANIZERS, INC.
4016-260-10
In Commercial Distribution

  • 00190707087531 ()


  • Orthodontic tube

Buccal Tube Direct Bond - 00190707087739

.022 UL6 Conv Com Buccal Tube Roth Ging DB
ORTHO ORGANIZERS, INC.
4016-363-10
In Commercial Distribution

  • 00190707087739 ()


  • Orthodontic tube

Buccal Tube Direct Bond - 00190707087722

.018 UR6 Conv Com Buccal Tube Roth Ging DB
ORTHO ORGANIZERS, INC.
4016-360-10
In Commercial Distribution

  • 00190707087722 ()


  • Orthodontic tube
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