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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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Brevera Breast Biopsy System - 35420045507832

Kit used with a stereotactic guidance system compatible with Brevera(R) .
Hologic, Inc.
BREVSTXKITM
In Commercial Distribution

  • 35420045507832 ()
BREVSTXKITM

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 35420045507801

Kit used with a stereotactic guidance system compatible with Brevera(R).
Hologic, Inc.
BREVSTXKIT
In Commercial Distribution

  • 35420045507801 ()
BREVSTXKIT

  • Mammographic stereotactic biopsy system

Z-Evo - 00810092938637

Endodontic motor with integrated apex locator with continuous and reciprocating rotation.
NUSMILE, LTD.
6080241
In Commercial Distribution

  • 00810092938637 ()


  • Dental surgical power tool motorized handpiece/set, electric

BAUM - 00810010920317

Roll-By With Adult Latex Calibrated V-Lok Inflation System With Circular Basket
W. A. BAUM CO., INC.
1150
In Commercial Distribution

  • 00810010920317 ()
1150

  • Aneroid manual sphygmomanometer

FENTEX - 04250407786670

Articulated arm with L-Column, with central one hand fixation, 40 cm
FENTEX medical GmbH
118970FX
In Commercial Distribution

  • 04250407786670 ()
118970FX

  • Surgical instrument assist arm system, manually-adjusted

devemed - 04061644037698

Crown pliers with silicone inserts with fixing screw F-LINE | PS | TF
devemed GmbH
7270-90 F
In Commercial Distribution

  • 04061644037698 ()


  • Dental prosthesis removal instrument

Nonin - 00833166001242

Xpod LP with 7000A, 6000CA for use with GE ApexPro CH
NONIN MEDICAL, INC.
3013 CH
In Commercial Distribution

  • 00833166001273 ()
  • 00833166001242 ()

  • Adult


  • Pulse oximeter probe, single-use
  • Pulse oximeter, line-powered
  • Pulse oximeter

KLARITY MEDICAL - 00817355023758

PelvicFix™ Bodycast with disposable frame with 42% perforation 3.2mm, 46x56cm
Klarity Medical Products, LLC
R902-3A
In Commercial Distribution

  • 00817355023758 ()


  • Patient positioning thermoplastic mould material

Double ENDOBUTTON - 00885556424544

ROUND ENDOBUTTON 2-HOLE WITH POST SST WITH SZ3/4 SUTURE LOOP
Smith & Nephew, Inc.
71934993
In Commercial Distribution

  • 00885556424544 ()
71934993

  • Tendon/ligament bone anchor, non-bioabsorbable

NA - 10888551028653

DRILL BIT OVERDRILL WITH AO CONNECTION FOR USE WITH 2.7MM SCREWS
STERILMED, INC.
STR703703
Not in Commercial Distribution

  • 10888551028653 ()
703703

  • Fluted surgical drill bit, single-use

BLOXR - 10811042031931

XPF® Frontal Apron with Elastic Back, XX-LARGE with Pregnancy Shield
BLOXR Solutions, LLC
10P425-
In Commercial Distribution

  • 10811042031931 ()


  • Radiation shielding apron

BLOXR - 10811042031924

XPF® Frontal Apron with Elastic Back, X-LARGE with Pregnancy Shield
BLOXR Solutions, LLC
10P424-
In Commercial Distribution

  • 10811042031924 ()


  • Radiation shielding apron

BLOXR - 10811042031917

XPF® Frontal Apron with Elastic Back, LARGE with Pregnancy Shield
BLOXR Solutions, LLC
10P423-
In Commercial Distribution

  • 10811042031917 ()


  • Radiation shielding apron

BLOXR - 10811042031900

XPF® Frontal Apron with Elastic Back,, MEDIUM with Pregnancy Shield
BLOXR Solutions, LLC
10P422-
In Commercial Distribution

  • 10811042031900 ()


  • Radiation shielding apron

BLOXR - 10811042031894

XPF® Frontal Apron with Elastic Back, SMALL with Pregnancy Shield
BLOXR Solutions, LLC
10P421-
In Commercial Distribution

  • 10811042031894 ()


  • Radiation shielding apron

BLOXR - 10811042031887

XPF® Frontal Apron with Elastic Back, X-SMALL with Pregnancy Shield
BLOXR Solutions, LLC
10P420-
In Commercial Distribution

  • 10811042031887 ()


  • Radiation shielding apron

ACUMEN IQ - 00690103205787

ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP 5-PACK
Edwards Lifesciences LLC
AIQSFM6AZ5
In Commercial Distribution

  • 50690103205782 ()
  • 00690103205787 ()
AIQSFM6AZ5

  • Intravenous line sensor, gravity infusion

Medline Industries, Inc. - 10195327619381

CATHETER REINF WITH CONNECTOR
MEDLINE INDUSTRIES, INC.
EPIREINFSTYL
In Commercial Distribution

  • 40195327619382 ()
  • 10195327619381 ()
EPIREINFSTYL

  • General surgical procedure kit, non-medicated, single-use

PILLING - 14026704810618

FCPS MICRO WITH TEETH
TELEFLEX INCORPORATED
IPN022177
In Commercial Distribution

  • 54026704810616 ()
  • 14026704810618 ()
P29007

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

PILLING - 14026704810267

FCPS ARTERY WITH RATCHET
TELEFLEX INCORPORATED
IPN926982
In Commercial Distribution

  • 54026704810265 ()
  • 14026704810267 ()
P28546

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