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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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Awl for humeral stem - 00889024301849

REAMER FOR HUMERAL STEM 9
Zimmer GmbH
72.02.20-09
In Commercial Distribution

  • 00889024301849 ()

  • 9
72.02.20-09

  • Joint prosthesis implantation kit, reusable

Alloclassic® - 00889024301511

No Description
Zimmer GmbH
6829
In Commercial Distribution

  • 00889024301511 ()

  • 9
6829

  • Femoral stem prosthesis trial

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

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 - 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 - 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 - 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 - 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

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 - 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 - 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

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 - 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 - 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

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

BIOLIGHT DRILL FREE - 10667147000477

BIOLIGHT DRILL FREE #9
Synca Marketing Inc
BDF09
Not in Commercial Distribution

  • 10667147100474 ()
  • 10667147000477 ()

  • 9


  • Root canal post, preformed

MASSAGE ROD 9CM - 14897076722034

No Description
TENS PLUS INDUSTRIAL COMPANY
Guasha.R.9
In Commercial Distribution

  • 14897076722034 ()


  • External manual massager, clinical

Neoscope - 00851545007623

NEOFLEX-FLEXIBLE VIDEO URETEROSCOPE
PROSURG INC
NFU 9
In Commercial Distribution

  • 00851545007623 ()
  • 10851545007620 ()

  • Catheter Gauge: 9.0 French


  • Flexible video ureteroscope, reusable

HairMax - 00856823006251

Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
Lexington International, LLC
Ultima 9
In Commercial Distribution

  • 00856823006251 ()


  • Hair growth laser device

VS 9 Vital Signs Monitor - 06936415973643

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
VS 9
In Commercial Distribution

  • 06936415973643 ()


  • General-purpose multi-parameter bedside monitor

Sublime Arís - 00643293026311

Sublime Arís Size 9
TRULIFE LIMITED
151 9
In Commercial Distribution

  • 00643293026311 ()


  • External breast prosthesis

E Supreme - 00643293000373

E Supreme Breast Protehsis Size 9
TRULIFE LIMITED
509 9
In Commercial Distribution

  • 00643293000373 ()


  • External breast prosthesis

Orfit Industries - 05420028784907

Pressure Belt with Manual Pump with belt of 120 cm
Orfit Industries NV
32317/9
In Commercial Distribution

  • 05420028784907 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028769911

1 set of 4 Swivel Clamps for UON®/DUON® Base Plate
Orfit Industries NV
32097/9
In Commercial Distribution

  • 05420028769911 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028757123

Grip Pole Complete System
Orfit Industries NV
32015/9
In Commercial Distribution

  • 05420028757123 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028706206

EVA Handle Set 13mm Light Blue Medium
Orfit Industries NV
32110/9
In Commercial Distribution

  • 05420028706206 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028700303

Set of HD Blocks and Wedges (2 blocks 20/40mm + 2 wedges 9°/13.5°)
Orfit Industries NV
35754/9
In Commercial Distribution

  • 05420028700303 ()


  • DNA-based tissue typing IVD, reagent

Hu-Friedy MFG Co., LLC - 10889950097158

#7/9 McCall DE Hoe Scaler
HU-FRIEDY MFG. CO., LLC
SM7/9
In Commercial Distribution

  • 10889950097158 ()


  • Periodontal hoe

Hu-Friedy MFG Co., LLC. - 10889950030650

#8/9 Orban DE Hoe Scaler
HU-FRIEDY MFG. CO., LLC
SO8/9
In Commercial Distribution

  • 10889950030650 ()


  • Periodontal hoe

Joint Jack Company - 00858534005066

No Description
Joint Jack Company
Joint-Spring 9"
In Commercial Distribution

  • 00858534005066 ()
1204

  • Hand/finger splint, single-use

Fisherbrand - 00613647002469

PRP 1.5X5 LATX FREE 48/CS
FISHER SCIENTIFIC COMPANY L.L.C.
KZ401.5-NO.9
In Commercial Distribution

  • 20613647002463 ()
  • 00613647002469 ()
  • 10613647002466 ()
22363113

  • Non-adhesive device retention bandage

Fisherbrand - 00613647002384

PRP 1X5 LATX FREE 30/CS
FISHER SCIENTIFIC COMPANY L.L.C.
KZ401-NO.9
In Commercial Distribution

  • 20613647002388 ()
  • 00613647002384 ()
  • 10613647002381 ()
22363102

  • Non-adhesive device retention bandage
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