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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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Tsolution One Surgical System - M9461033050

POST, RECOVERY MARKER 125
THINK SURGICAL, INC.
103305
In Commercial Distribution

  • M9461033050 ()

  • Length: 125 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Tsolution One Surgical System - M9461027940

POSTS, RECOVERY MARKER 11, PACKAGED
THINK SURGICAL, INC.
102794
In Commercial Distribution

  • M9461027942 ()
  • M9461027940 ()

  • Length: 11 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Tsolution One Surgical System - M9461026130

POST, RECOVERY MARKER 11
THINK SURGICAL, INC.
102613
In Commercial Distribution

  • M9461026130 ()

  • Length: 11 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

One Step Menopausal Test - B512210011

No Description
UNIVERSAL MEDITECH INC.
21001
In Commercial Distribution

  • B512210011 ()
210-01

  • Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Ambler Surgical - 00190660181529

Fisher spoon and needle, 5 3/8'', double-ended, one needle point end and one 5.0mm x 14.0mm thin, curved blade, flat handle
AMBLER SURGICAL CORP.
Fisher spoon and needle
In Commercial Distribution

  • 00190660181529 ()
6868E

  • Ocular hook/spatula/manipulator, reusable

laserwhite20 Whitening Gel - 00647529000113

laserwhite20 Whitening Gel contains 5 patient treatment kits. Each kit contains one syringe of whitening gel base, one syringe of gel activator, one syringe of liquid dam and one syringe of desensitizer. Accessories such as applicators are also included. The product is intended for use with Biolase diode lasers.
Biolase, Inc.
laserwhite20
In Commercial Distribution

  • 00647529000113 ()
  • 00647529000281 ()
7400030

  • Dental coating, tooth-desensitizing

Xeno® IV One Component Light Cured Self-Etching Dental Adhesive - D0026680011

Xeno® IV One Component Self-Etching Dental Adhesive Introductory Kit
DENTSPLY INTERNATIONAL INC.
668001
In Commercial Distribution

  • D0026680011 ()

  • 1 Bottle Xeno® IV (4.5mL), 100 Flocked Applicator Tips, 1 Dispensing Well
  • Total Volume: 4.5 Milliliter
668001

  • Dentine adhesive

PARA CPX - 00857915007606

PARA Cross Pin External Fixation Frame and One Tightening Tool
A.M. SURGICAL, INC.
8800-10
In Commercial Distribution

  • 00857915007606 ()
N/A

  • External orthopaedic fixation system, single-use, sterile

HELMUT ZEPF - EZPF85194180

WASHBASKET 1/2, 178X135X37MM, FOR 3D ONE STEP AUGMENTATION KIT
Helmut Zepf Medizintechnik GmbH
85.194.18
In Commercial Distribution

  • EZPF85194180 ()
85.194.18

  • Instrument transport trolley system

ANTHEM - 00889095404814

ANTHEM One Third Tubular Plate, Non-Locking, 14 Hole, 168mm, SS
GLOBUS MEDICAL, INC.
2179.1334
In Commercial Distribution

  • 00889095404814 ()

  • Length: 168 Millimeter
  • 14 Hole


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
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