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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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26MM X 3CM X 105CM NOVAFLEX+ DELIVERY SYSTEM - 00690103193237

No Description
Edwards Lifesciences LLC
9355FS26
In Commercial Distribution

  • 00690103193237 ()

  • 26 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9355FS26A

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

23MM X 3CM X 105CM NOVAFLEX+ DELIVERY SYSTEM - 00690103193220

No Description
Edwards Lifesciences LLC
9355FS23
In Commercial Distribution

  • 00690103193220 ()

  • 23 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9355FS23A

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

23MM X 4CM X 130CM EDWARDS BALLOON CATHETER - 00690103191820

EDWARDS BALLOON CATHETER
Edwards Lifesciences LLC
9350BC23
In Commercial Distribution

  • 00690103191820 ()

  • 23 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9350BC23A

  • Cardiac valvuloplasty catheter

20MM X 4CM X 130CM EDWARDS BALLOON CATHETER - 00690103191813

EDWARDS BALLOON CATHETER
Edwards Lifesciences LLC
9350BC20
In Commercial Distribution

  • 00690103191813 ()

  • 20 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9350BC20A

  • Cardiac valvuloplasty catheter

Stackable Steptool Footstool 24 x 12 x 8 - 00690521014893

Stackable Steptool Footstool 24 x 12 x 8
Batrik Medical Manufacturing Inc
OR-36360-B
In Commercial Distribution

  • 00690521014893 ()
OR-36360-B

  • Footstool

6ft x 1/4 x 1/16 Tubing - 00607567200159

No Description
DATASCOPE CORP.
BEQ- 20102
Not in Commercial Distribution

  • 00607567200159 ()
701048429

  • Cardiopulmonary bypass system blood tubing set

MEMOSIL 2 1 X (2 X 50 ML) - J014660049691

Dental Composite resin
Kulzer GmbH
66004969
In Commercial Distribution

  • J014660049691 ()
66004969

  • Dental composite resin

MEMOSIL 2 3 X (2 X 50 ML) - J014660049690

Material Impression
Kulzer GmbH
66004969
Not in Commercial Distribution

  • J014660049690 ()
66004969

  • Polyether dental impression material

MEMOREG 2 1 X (2 X 50 ML) - J014660049651

Dental Composite resin
Kulzer GmbH
66004965
In Commercial Distribution

  • J014660049651 ()
66004965

  • Dental composite resin

MEMOREG 2 3 X (2 X 50 ML) - J014660049650

Material Impression
Kulzer GmbH
66004965
Not in Commercial Distribution

  • J014660049650 ()
66004965

  • Polyether dental impression material

AOS TROCHANTERIC NAIL 13mm x 17cm x 125° - 00848665014686

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
1033-170
In Commercial Distribution

  • 00848665014686 ()


  • Femur nail, non-sterile

AOS TROCHANTERIC NAIL 12mm x 17cm x 125° - 00848665014662

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
1032-170
In Commercial Distribution

  • 00848665014662 ()


  • Femur nail, non-sterile

AOS TROCHANTERIC NAIL 11mm x 17cm x 125° - 00848665014648

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
1031-170
In Commercial Distribution

  • 00848665014648 ()


  • Femur nail, non-sterile

AOS TROCHANTERIC NAIL 11mm x 20cm x 120° - 00848665004861

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
1082-200
In Commercial Distribution

  • 00848665004861 ()


  • Femur nail, non-sterile

AOS TROCHANTERIC NAIL 11mm x 17cm x 120° - 00848665004854

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
1082-170
In Commercial Distribution

  • 00848665004854 ()


  • Femur nail, non-sterile

AOS TROCHANTERIC NAIL 12mm x 20cm x 130° - 00848665003826

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1041-200
Not in Commercial Distribution

  • 00848665003826 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 12mm x 17cm x 130° - 00848665003819

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1041-170
Not in Commercial Distribution

  • 00848665003819 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 10mm x 20cm x 130° - 00848665003802

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1040-200
Not in Commercial Distribution

  • 00848665003802 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 10mm x 17cm x 130° - 00848665003796

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1040-170
Not in Commercial Distribution

  • 00848665003796 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 13mm x 20cm x 130° - 00848665003741

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1037-200
Not in Commercial Distribution

  • 00848665003741 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 13mm x 17cm x 130° - 00848665003734

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1037-170
Not in Commercial Distribution

  • 00848665003734 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 11mm x 20cm x 130° - 00848665003727

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1036-200
Not in Commercial Distribution

  • 00848665003727 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 11mm x 17cm x 130° - 00848665003710

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1036-170
Not in Commercial Distribution

  • 00848665003710 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 9mm x 20cm x 130° - 00848665003680

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1034-200
Not in Commercial Distribution

  • 00848665003680 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 9mm x 17cm x 130° - 00848665003673

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1034-170
Not in Commercial Distribution

  • 00848665003673 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 13mm x 20cm x 125° - 00848665003666

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1033-200
Not in Commercial Distribution

  • 00848665003666 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 13mm x 17cm x 125° - 00848665003659

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1033-170
Not in Commercial Distribution

  • 00848665003659 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 12mm x 20cm x 125° - 00848665003642

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1032-200
Not in Commercial Distribution

  • 00848665003642 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 12mm x 17cm x 125° - 00848665003635

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1032-170
Not in Commercial Distribution

  • 00848665003635 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 11mm x 20cm x 125° - 00848665003628

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1031-200
Not in Commercial Distribution

  • 00848665003628 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 11mm x 17cm x 125° - 00848665003611

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1031-170
Not in Commercial Distribution

  • 00848665003611 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 10mm x 20cm x 125° - 00848665003604

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1030-200
Not in Commercial Distribution

  • 00848665003604 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 10mm x 17cm x 125° - 00848665003598

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1030-170
Not in Commercial Distribution

  • 00848665003598 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 9mm x 20cm x 125° - 00848665003581

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1029-200
Not in Commercial Distribution

  • 00848665003581 ()


  • Femur intramedullary nail

AOS TROCHANTERIC NAIL 9mm x 17cm x 125° - 00848665003574

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1029-170
Not in Commercial Distribution

  • 00848665003574 ()


  • Femur intramedullary nail

AQUARI SURFACE 32 x 16 x 3.5 PEDI - 00842430115882

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
246-PEDIHEART
Not in Commercial Distribution

  • 00842430115882 ()
246-PEDIHEART

  • Operating table patient pressure distribution monitoring/regulation system

TEMPUR-MED STRETCHER MATTRESS 26.5 X 78 X 3 - 00842430114267

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69265
In Commercial Distribution

  • 00842430114267 ()
69265

  • Stretcher mattress

24" X 75.5" X 3" TEMPUR-MED STRETCHER MATTRESS - 00842430114250

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69024
Not in Commercial Distribution

  • 00842430114250 ()
69024

  • Stretcher mattress

TEMPUR-MED STRETCHER MATTRESS 26 X 75.5 X 3 - 00842430111044

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69026
In Commercial Distribution

  • 00842430111044 ()
69026

  • Stretcher mattress

TEMPUR-MED STRETCHER MATTRESS 29.5 X 75.5 X 3 - 00842430111037

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69295
In Commercial Distribution

  • 00842430111037 ()
69295

  • Stretcher mattress
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