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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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IDEAL IMPLANT - 10851795006015

Round, smooth-surface, saline-filled breast implant.
IDEAL IMPLANT INCORPORATED
24001
In Commercial Distribution

  • 10851795006015 ()

  • Total Volume, 240 cc
240

  • Saline-filled breast implant, unstructured

IDEAL IMPLANT - 10851795006008

Round, smooth-surface, saline-filled breast implant.
IDEAL IMPLANT INCORPORATED
21001
In Commercial Distribution

  • 10851795006008 ()

  • Total Volume, 210 cc
210

  • Saline-filled breast implant, unstructured

Dover - 10884521003583

Hydrogel Coated Latex Foley Catheter Kit,2-Way
Cardinal Health, Inc.
1818
Not in Commercial Distribution

  • 20884521003580 ()
  • 10884521003583 ()

  • Total Volume,5,CC;
  • Catheter Gauge: 18 French
1818

  • Indwelling urethral catheterization kit, adult

Dover - 10884521003569

Hydrogel Coated Latex Foley Catheter Kit,2-Way
Cardinal Health, Inc.
1817
Not in Commercial Distribution

  • 20884521003566 ()
  • 10884521003569 ()

  • Total Volume,5,CC;
  • Catheter Gauge: 16 French
1817

  • Indwelling urethral catheterization kit, adult

EndoCurette - H671CUR1200

Endometrial Suction Curette with Syringe
UTAH MEDICAL PRODUCTS, INC.
Clear
In Commercial Distribution

  • H671CUR1201 ()
  • H671CUR1200 ()

  • Syringe Volume - 20 cc
  • Length: 27 Centimeter
  • Outer Diameter: 3.1 Millimeter
CUR-120

  • Endometrial biopsy curette

Clearblue - 00633472602375

A convenience kit consisting of 15 Digital Ovulation Tests, Digital Basal Thermometer and 3 month subscription to Natural Cycles app
SPD SWISS PRECISION DIAGNOSTICS GMBH
Birth Control Kit
In Commercial Distribution

  • 10633472602372 ()
  • 00633472602375 ()
N/A

  • Natural conception assistance kit

OTIS-C PLUS - 03760154004152

NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
S.B.M
NON STERILE Screw for OTIS-C PLUS plate fixation
Not in Commercial Distribution

  • 03760154004152 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 70 Millimeter
EVONS66070

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

Best Medical International - 00841365115394

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageSize=25&pageMode=read+only&currentPage=0&deviceRecordKey=141332#
BEST MEDICAL INTERNATIONAL, INC.
1164-1-40
In Commercial Distribution

  • 00841365115394 ()


  • General-purpose brachytherapy system applicator, remote-afterloading

VCA Lite - 00860009492912

5.3 cc Vaginal Cream Applicator 3-Pack. Three applicators are packaged in a canister.
Pce, Inc.
Q033-G00-02
In Commercial Distribution

  • 00860009492912 ()


  • Vaginal applicator, single-use

PET PIG - 00718175001806

Pig, Double-Ended, PET, .6" lead, accommodates 5 cc syringes with or without needle
BIODEX MEDICAL SYSTEMS, INC.
001-793
In Commercial Distribution

  • 00718175001806 ()
001-793

  • Radiation shielding container, transport/transfer
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