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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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PALACOS® - 04260102136007

The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOS® R+G powder and monomer liquid. PALACOS® R+G pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Heraeus Medical GmbH
R+G pro
In Commercial Distribution

  • 04260102136007 ()
  • 04260102136021 ()
  • 04260102136014 ()
5075298

  • Orthopaedic cement, antimicrobial

PURE-Ca-SEAL - 07898078659465

Bioceramic root canal sealer ready-to-use.
Angelus Industria de Produtos Odontologicos S A
PURE-Ca-SEAL 0.5 g
In Commercial Distribution

  • 07898078659465 ()
3971

  • Hygroscopic dental cement

PURE-Ca-SEAL - 07898078651605

Bioceramic root canal sealer ready-to-use.
Angelus Industria de Produtos Odontologicos S A
PURE-Ca-SEAL 2 g
In Commercial Distribution

  • 07898078651605 ()
3970

  • Hygroscopic dental cement

b-ONE™ Primary Acetabular System - 00843575102478

Acetabular Liner, Hooded, 10 degree; Vitamin E UHMWPE; 36mm Inner Diameter, Size G
B-ONE ORTHO, CORP.
881201361G
In Commercial Distribution

  • 00843575102478 ()
881201361G

  • Non-constrained polyethylene acetabular liner

b-ONE™ Primary Acetabular System - 00843575102447

Acetabular Liner, Hooded, 10 degree; Vitamin E UHMWPE; 32mm Inner Diameter, Size G
B-ONE ORTHO, CORP.
881201321G
In Commercial Distribution

  • 00843575102447 ()
881201321G

  • Non-constrained polyethylene acetabular liner

b-ONE™ Primary Acetabular System - 00843575102416

Acetabular Liner, Hooded, 10 degree; Vitamin E UHMWPE; 28mm Inner Diameter, Size G
B-ONE ORTHO, CORP.
881201281G
In Commercial Distribution

  • 00843575102416 ()
881201281G

  • Non-constrained polyethylene acetabular liner

b-ONE™ Primary Acetabular System - 00843575102317

Acetabular Liner, Neutral, 0 degree; Vitamin E UHMWPE; 36mm Inner Diameter, Size G
B-ONE ORTHO, CORP.
881200361G
In Commercial Distribution

  • 00843575102317 ()
881200361G

  • Non-constrained polyethylene acetabular liner

b-ONE™ Primary Acetabular System - 00843575102287

Acetabular Liner, Neutral, 0 degree; Vitamin E UHMWPE; 32mm Inner Diameter, Size G
B-ONE ORTHO, CORP.
881200321G
In Commercial Distribution

  • 00843575102287 ()
881200321G

  • Non-constrained polyethylene acetabular liner

b-ONE™ Primary Acetabular System - 00843575102256

Acetabular Liner, Neutral, 0 degree; Vitamin E UHMWPE; 28mm Inner Diameter, Size G
B-ONE ORTHO, CORP.
881200281G
In Commercial Distribution

  • 00843575102256 ()
881200281G

  • Non-constrained polyethylene acetabular liner

Premicath - 00849884002317

PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND MICROFLASH INTRODUCER
Vygon Corporation
1261.208G
In Commercial Distribution

  • 30849884002318 ()
  • 00849884002317 ()

  • Outer Diameter: 24 Millimeter
1261.208G

  • Peripherally-inserted central venous catheter
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