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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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Actinia® - 04048844196547

broach
implantcast GmbH
80049009
In Commercial Distribution

  • 04048844196547 ()

  • 9


  • Orthopaedic broach

implaFit® broach - 04048844481643

No Description
implantcast GmbH
80082009
In Commercial Distribution

  • 04048844481643 ()

  • 9


  • Orthopaedic broach

implaFit® hip stem cementless lateralized - 04048844477288

No Description
implantcast GmbH
80020009
In Commercial Distribution

  • 04048844477288 ()

  • 9


  • Coated femoral stem prosthesis, one-piece

implaFit® hip stem cementless standard - 04048844477189

No Description
implantcast GmbH
80030009
In Commercial Distribution

  • 04048844477189 ()

  • 9


  • Coated femoral stem prosthesis, one-piece

Humeris Shoulder - 03701037306550

RASP SIZE 09
FX SOLUTIONS
910-0209
In Commercial Distribution

  • 03701037306550 ()

  • 9
910-0209

  • Bone file/rasp, manual, reusable
  • Orthopaedic surgical procedure kit, non-medicated, reusable

ENCORE - 10884792170908

ENCORE® Sensi-Touch PF Size 9, Sterile Latex Powder-Free Surgical Glove
Ansell Healthcare Product
7828PF
In Commercial Distribution

  • 20884792170905 ()
  • 10884792170908 ()
  • 30884792170902 ()
  • 00071483002096 ()

  • 9
7828PF

  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

ENCORE - 10884792160909

ENCORE® Perry Style 42 PF Size 9, Sterile Latex Powder-Free Surgical Glove
Ansell Healthcare Product
5711107PF
In Commercial Distribution

  • 20884792160906 ()
  • 10884792160909 ()
  • 30884792160903 ()
  • 00071483002171 ()

  • 9
5711107PF

  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

UTS Stem, Ti plasma spray, high offset - 04719872156420

UTS Stem, Ti plasma spray, high offset, #9
UNITED ORTHOPEDIC CORP.
1106-5209
In Commercial Distribution

  • 04719872156420 ()

  • #9
1106-5209

  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular

UTS Stem, Ti plasma spray - 04719872156284

UTS Stem, Ti plasma spray, #9
UNITED ORTHOPEDIC CORP.
1106-5009
In Commercial Distribution

  • 04719872156284 ()

  • #9
1106-5009

  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular

United Hip System, UTF Stem, Ti Plasma Spray, High Offset - 04712771495669

UTF stem, Ti plasma spray, high offset, #9
UNITED ORTHOPEDIC CORP.
1106-1209
In Commercial Distribution

  • 04712771495669 ()

  • #9
1106-1209

  • Coated hip femur prosthesis, modular
  • Revision coated hip femur prosthesis

United Hip System, UTF Stem, Ti Plasma Spray - 04712771495560

UTF stem, Ti plasma spray, #9
UNITED ORTHOPEDIC CORP.
1106-1009
In Commercial Distribution

  • 04712771495560 ()

  • #9
1106-1009

  • Coated hip femur prosthesis, modular
  • Revision coated hip femur prosthesis

United Hip System, UTF Stem, Reduced, Ti Plasma Spray - 04712771505160

UTF stem, reduced, Ti plasma spray, #9
UNITED ORTHOPEDIC CORP.
1106-3009
In Commercial Distribution

  • 04712771505160 ()

  • #9
1106-3009

  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular

United Hip System, UTF Stem, Reduced, Ti Plasma Spray, High Offset - 04712771505023

UTF stem, reduced, Ti plasma spray, high offset, #9
UNITED ORTHOPEDIC CORP.
1106-3209
In Commercial Distribution

  • 04712771505023 ()

  • #9
1106-3209

  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular

UTF™ Stem - 04719872167167

UTF Broach, #9
UNITED ORTHOPEDIC CORP.
9106-6009
In Commercial Distribution

  • 04719872167167 ()

  • #9
9106-6009

  • Orthopaedic broach

Integra® Jarit® - 10381780180890

Integra® Jarit® Mayo Russian Tissue Forceps, 9", Fenestrated Jaws, Slotted Grooved Handle
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
130397
In Commercial Distribution

  • M2741303971 ()
  • 10381780180890 ()

  • 9"
130-397

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

BethaLoc® - 04048844236021

broach
implantcast GmbH
87001059
In Commercial Distribution

  • 04048844236021 ()

  • 9


  • Orthopaedic broach

Struxxure® MCS Anterior Cervical System - 00889929069080

4-Hole Plate Trial, Size 09
NEXXT SPINE, LLC
I33-4PT-09
In Commercial Distribution

  • 00889929069080 ()

  • 9


  • General internal orthopaedic fixation system implantation kit

Struxxure® MCS Anterior Cervical System - 00889929069028

3-Hole Plate Trial, Size 09
NEXXT SPINE, LLC
I33-3PT-09
In Commercial Distribution

  • 00889929069028 ()

  • 9


  • General internal orthopaedic fixation system implantation kit

Struxxure® MCS Anterior Cervical System - 00889929068960

2-Hole Plate Trial, Size 09
NEXXT SPINE, LLC
I33-2PT-09
In Commercial Distribution

  • 00889929068960 ()

  • 9


  • General internal orthopaedic fixation system implantation kit

GAMMEX - 00884792387279

GAMMEX® Non-Latex PI Underglove Size 9, Sterile Polyisoprene Powder-Free Surgical Glove
Ansell Healthcare Product
20687290
In Commercial Distribution

  • 20884792387273 ()
  • 00884792387279 ()
  • 30884792387270 ()
  • 00071483001105 ()

  • 9
20687290

  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

GAMMEX - 00884792385572

GAMMEX® Non-Latex PI Moisturizing Size 9, Sterile Polyisoprene Powder-Free Surgical Glove
Ansell Healthcare Product
20685590
In Commercial Distribution

  • 20884792385576 ()
  • 00884792385572 ()
  • 30884792385573 ()
  • 00071483001020 ()

  • 9
20685590

  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

GAMMEX - 00884792385176

GAMMEX® Non-Latex Size 9, Sterile Neoprene Powder-Free Surgical Glove
Ansell Healthcare Product
8518
In Commercial Distribution

  • 20884792385170 ()
  • 00884792385176 ()
  • 30884792385177 ()
  • 00071483000702 ()

  • 9
8518

  • Polychloroprene surgical glove, non-powdered

GAMMEX - 00884792377270

GAMMEX® Non-Latex Sensitive Size 9, Sterile Neoprene Powder-Free Surgical Glove
Ansell Healthcare Product
20277290
In Commercial Distribution

  • 20884792377274 ()
  • 00884792377270 ()
  • 30884792377271 ()
  • 00071483000542 ()

  • 9
20277290

  • Polychloroprene surgical glove, non-powdered

ENCORE - 00884792308878

ENCORE® Latex Ortho Size 9, Sterile Latex Powder-Free Surgical Glove
Ansell Healthcare Product
5788007
In Commercial Distribution

  • 20884792308872 ()
  • 00884792308878 ()
  • 30884792308879 ()
  • 00071483000382 ()

  • 9
5788007

  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

ENCORE - 00884792308779

ENCORE® Latex Micro Size 9, Sterile Latex Powder-Free Surgical Glove
Ansell Healthcare Product
5787007
In Commercial Distribution

  • 20884792308773 ()
  • 00884792308779 ()
  • 30884792308770 ()
  • 00071483000467 ()

  • 9
5787007

  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

ENCORE - 00884792308472

ENCORE® Latex Underglove Size 9, Sterile Latex Powder-Free Surgical Glove
Ansell Healthcare Product
2018490
In Commercial Distribution

  • 20884792308476 ()
  • 00884792308472 ()
  • 30884792308473 ()
  • 00071483000238 ()

  • 9
2018490

  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

ENCORE - 00884792209571

ENCORE® Latex Acclaim Size 9, Sterile Latex Powder-Free Surgical Glove
Ansell Healthcare Product
5795007
In Commercial Distribution

  • 20884792209575 ()
  • 00884792209571 ()
  • 30884792209572 ()
  • 00071483000078 ()

  • 9
5795007

  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

GAMMEX - 00884792188272

GAMMEX® Non-Latex PI Textured Size 9, Sterile Polyisoprene Powder-Free Surgical Glove
Ansell Healthcare Product
20688290
In Commercial Distribution

  • 20884792188276 ()
  • 00884792188272 ()
  • 30884792188273 ()
  • 00071483000948 ()

  • 9
20688290

  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

GAMMEX - 00884792185776

GAMMEX® Non-Latex PI Size 9, Sterile Polyisoprene Powder-Free Surgical Glove
Ansell Healthcare Product
20685790
In Commercial Distribution

  • 20884792185770 ()
  • 00884792185776 ()
  • 30884792185777 ()
  • 00071483000863 ()

  • 9
20685790

  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

GAMMEX - 00884792386579

GAMMEX® Non-Latex PI Ortho Size 9, Sterile Polyisoprene Powder-Free Surgical Glove
Ansell Healthcare Product
20686590
In Commercial Distribution

  • 20884792386573 ()
  • 00884792386579 ()
  • 30884792386570 ()
  • 00071483001259 ()

  • 9
20686590

  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

GAMMEX - 00884792385275

GAMMEX® Non-Latex PI Green Size 9, Sterile Polyisoprene Powder-Free Surgical Glove
Ansell Healthcare Product
20685290
In Commercial Distribution

  • 20884792385279 ()
  • 00884792385275 ()
  • 30884792385276 ()
  • 00071483000788 ()

  • 9
20685290

  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

ENCORE - 00884792308571

ENCORE® Latex Textured Size 9, Sterile Latex Powder-Free Surgical Glove
Ansell Healthcare Product
5785007
In Commercial Distribution

  • 20884792308575 ()
  • 00884792308571 ()
  • 30884792308572 ()
  • 00071483000313 ()

  • 9
5785007

  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

ENCORE - 00884792208673

ENCORE® Latex Moisturizing Size 9, Sterile Latex Powder-Free Surgical Glove
Ansell Healthcare Product
2018690
In Commercial Distribution

  • 20884792208677 ()
  • 00884792208673 ()
  • 30884792208674 ()
  • 00071483000153 ()

  • 9
2018690

  • Hevea-latex surgical glove, non-powdered, non-antimicrobial

GAMMEX - 00884792185974

GAMMEX® Non-Latex PI Micro Size 9, Sterile Polyisoprene Powder-Free Surgical Glove
Ansell Healthcare Product
20685990
In Commercial Distribution

  • 20884792185978 ()
  • 00884792185974 ()
  • 30884792185975 ()
  • 00071483001181 ()

  • 9
20685990

  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

VIA Spinous Process Fixation System - M7404400037

9mm Modular Inserter
SPINEOLOGY INC.
34-12-08
In Commercial Distribution

  • M7404400037 ()

  • 9
  • Length: 9 Millimeter
440-0037

  • Orthopaedic inorganic implant inserter/extractor, reusable

VIA Spinous Process Fixation System - M7404400019

9mm Rasp
SPINEOLOGY INC.
34-06-05
In Commercial Distribution

  • M7404400019 ()

  • Length: 9 Millimeter
  • 9
440-0019

  • Bone file/rasp, manual, reusable

GAMMEX - 15414566842905

GAMMEX® PI Glove-in-Glove™ System Size 9, Sterile Powder-Free Surgical Glove, pre-donned double gloving system of one polyisoprene (PI) surgical glove and one neoprene surgical glove
Ansell Healthcare Product
340084090
In Commercial Distribution

  • 25414566842902 ()
  • 15414566842905 ()
  • 35414566842909 ()
  • 00071483001808 ()

  • 9
340084090

  • Polychloroprene surgical glove, non-powdered
  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

GAMMEX - 15414566642901

GAMMEX® PI Ergo-Fit Size 9, Sterile Polyisoprene Powder-Free Surgical Glove
Ansell Healthcare Product
340064090
In Commercial Distribution

  • 25414566642908 ()
  • 15414566642901 ()
  • 35414566642905 ()
  • 00071483001969 ()

  • 9
340064090

  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

GAMMEX - 15414566630908

GAMMEX® PI Hybrid Size 9, Sterile Powder-Free Surgical Glove, Polyisoprene and Neoprene Blend
Ansell Healthcare Product
340063090
In Commercial Distribution

  • 25414566630905 ()
  • 15414566630908 ()
  • 35414566630902 ()
  • 00071483001419 ()

  • 9
340063090

  • Polychloroprene surgical glove, non-powdered
  • Polyisoprene surgical glove, non-powdered, non-antimicrobial

GAMMEX - 15414566600901

GAMMEX® Non-Latex Underglove Size 9, Sterile Neoprene Powder-Free Surgical Glove
Ansell Healthcare Product
340060090
In Commercial Distribution

  • 25414566600908 ()
  • 15414566600901 ()
  • 35414566600905 ()
  • 00071483001334 ()

  • 9
340060090

  • Polychloroprene surgical glove, non-powdered
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