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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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gSource - 00840314249074

g2 Fox Curette 5 3/4" 4.0mm round
GSOURCE LLC
CD.50.5980
In Commercial Distribution

  • 00840314249074 ()
CD.50.5980

  • General-purpose curette

gSource - 00840314249081

g2 Fox Curette 5 3/4" 6.0mm round
GSOURCE LLC
CD.50.6000
In Commercial Distribution

  • 00840314249081 ()
CD.50.6000

  • General-purpose curette

gSource - 00840314249067

g2 Fox Curette 5 3/4" 2.0mm round
GSOURCE LLC
CD.50.5960
In Commercial Distribution

  • 00840314249067 ()
CD.50.5960

  • General-purpose curette

EL400 - 04560224986819

No Description
NAKANISHI INC.
EL400 CD
Not in Commercial Distribution

  • 04560224986819 ()


  • Dental power tool system, line-powered

NLX - 04560264572829

No Description
NAKANISHI INC.
NLX CD
In Commercial Distribution

  • 04560264572829 ()


  • Surgical power tool system control unit, line-powered

NLZ - 04560264551268

No Description
NAKANISHI INC.
NLZ CD
In Commercial Distribution

  • 04560264551268 ()


  • Surgical power tool system control unit, line-powered

AED - 00848657011198

Cysto Bridge
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
26068 CD
In Commercial Distribution

  • 00848657011198 ()


  • Rigid optical cystoscope

Gimmi - 04049047295846

MORSE RIB SPREADER FOR ADULTS, VALVE 19 X 29 MM SPREAD 200 MM
Gimmi GmbH
CD.1172.01
In Commercial Distribution

  • 04049047295846 ()
CD.1172.01

  • Rib spreader, reusable

Gimmi - 04049047176527

MORSE RIB SPREADER FOR CHILDREN, VALVE 12 X 20 MM SPREAD 200 MM
Gimmi GmbH
CD.1172.02
In Commercial Distribution

  • 04049047176527 ()
CD.1172.02

  • Rib spreader, reusable

Gimmi - 04049047034544

COOLEY RIB SPREADER ALU, FOR ADULTS, BLADE 21 X 44 MM SPREAD 140 MM
Gimmi GmbH
CD.1163.03
In Commercial Distribution

  • 04049047034544 ()
CD.1163.03

  • Rib spreader, reusable

Gimmi - 04049047034520

COOLEY RIB SPREADER; ALU, FOR NEWBORNS, BLADE 12 X 16 MM; SPREAD 70 MM
Gimmi GmbH
CD.1163.01
In Commercial Distribution

  • 04049047034520 ()
CD.1163.01

  • Rib spreader, reusable

Gimmi - 04049047696391

FINOCCHIETTO-BURFORD RIB SPREADER 2 PAIRS OF BLADES 80 X 67/ 40 X 67 MM SPREAD 250 MM
Gimmi GmbH
CD.1179.00
In Commercial Distribution

  • 04049047696391 ()
CD.1179.00

  • Rib spreader, reusable

Gimmi - 04049047696353

FINOCCHIETTO-BABY-HAIGHT RIB SPREADER ALUMINIUM, BLADE 31 X 31 MM SPREAD 80 MM
Gimmi GmbH
CD.1162.00
In Commercial Distribution

  • 04049047696353 ()
CD.1162.00

  • Rib spreader, reusable

Gimmi - 04049047034964

ALLISON LUNG SPATULA 40 MM LENGTH 270 MM
Gimmi GmbH
CD.1234.30
In Commercial Distribution

  • 04049047034964 ()
CD.1234.30

  • Lung spatula

Gimmi - 04049047034872

FINOCCHIETTO RIB SPREADER BLADE 65 X 70 MM SPREAD 250 MM
Gimmi GmbH
CD.1181.03
In Commercial Distribution

  • 04049047034872 ()
CD.1181.03

  • Rib spreader, reusable

Gimmi - 04049047034865

FINOCCHIETTO RIB SPREADER BLADE 50 X 65 MM SPREAD 200 MM
Gimmi GmbH
CD.1181.02
In Commercial Distribution

  • 04049047034865 ()
CD.1181.02

  • Rib spreader, reusable

Gimmi - 04049047034858

FINOCCHIETTO RIB SPREADER BLADE 40 X 45 MM SPREAD 165 MM
Gimmi GmbH
CD.1181.01
In Commercial Distribution

  • 04049047034858 ()
CD.1181.01

  • Rib spreader, reusable

Gimmi - 04049047034841

FINOCCHIETTO-BABY RIB SPREADER BLADE 19 X 20 MM SPREAD 75 MM
Gimmi GmbH
CD.1180.00
In Commercial Distribution

  • 04049047034841 ()
CD.1180.00

  • Rib spreader, reusable

Gimmi - 04049047034834

TUFFIER RIB SPREADER BLADE 50 X 45 MM SPREAD 165 MM
Gimmi GmbH
CD.1177.00
In Commercial Distribution

  • 04049047034834 ()
CD.1177.00

  • Rib spreader, reusable

Gimmi - 04049047034711

DEBAKEY RIB SPREADER COMPLETE, WITH 3 BLADES SPREAD 150 MM
Gimmi GmbH
CD.1173.00
In Commercial Distribution

  • 04049047034711 ()
CD.1173.00

  • Rib spreader, reusable

Gimmi - 04049047034704

MORSE-FAVALORO RIB SPREADER BLADE 38 X 28 MM SPREAD 200 MM
Gimmi GmbH
CD.1172.00
In Commercial Distribution

  • 04049047034704 ()
CD.1172.00

  • Rib spreader, reusable

Gimmi - 04049047034667

CASTENADA RIB SPREADER ALU, FOR CHILDREN, BLADE 12 X 45 MM SPREAD 70 MM
Gimmi GmbH
CD.1169.02
In Commercial Distribution

  • 04049047034667 ()
CD.1169.02

  • Rib spreader, reusable

Gimmi - 04049047034650

CASTENADA RIB SPREADER ALU, FOR NEWBORNS, BLADE 10.5 X 32 MM SPREAD 65 MM
Gimmi GmbH
CD.1169.01
In Commercial Distribution

  • 04049047034650 ()
CD.1169.01

  • Rib spreader, reusable

Gimmi - 04049047034636

BURFORD RIB SPREADER ALU, FOR ADULTS, 65 X 62/ 47 X 62 MM SPREAD 250 MM
Gimmi GmbH
CD.1167.02
In Commercial Distribution

  • 04049047034636 ()
CD.1167.02

  • Rib spreader, reusable

Gimmi - 04049047034612

BURFORD RIB SPREADER ALU, FOR CHILDREN, 41 X 42/ 30 X 42 MM SPREAD 130 MM
Gimmi GmbH
CD.1167.00
In Commercial Distribution

  • 04049047034612 ()
CD.1167.00

  • Rib spreader, reusable

Gimmi - 04049047034605

FINOCCHIETTO RIB SPREADER ALUMINIUM, BLADE 64 X 65 MM SPREAD 175 MM
Gimmi GmbH
CD.1166.03
In Commercial Distribution

  • 04049047034605 ()
CD.1166.03

  • Rib spreader, reusable

Gimmi - 04049047034599

FINOCCHIETTO RIB SPREADER ALUMINIUM, BLADE 40 X 62 MM SPREAD 175 MM
Gimmi GmbH
CD.1166.02
In Commercial Distribution

  • 04049047034599 ()
CD.1166.02

  • Rib spreader, reusable

Gimmi - 04049047034582

FINOCCHIETTO RIB SPREADER ALUMINIUM, BLADE 30 X 45 MM SPREAD 140 MM
Gimmi GmbH
CD.1166.01
In Commercial Distribution

  • 04049047034582 ()
CD.1166.01

  • Rib spreader, reusable

A. Titan Instruments - 00841685101947

Step-by-step instructions in Powerpoint program
A. TITAN INSTRUMENTS, INC.
XT CD
In Commercial Distribution

  • 00841685101947 ()


  • Tooth extraction forceps

Millennium - 00190776094959

Frazier Suction Tube, RoundSlot
Avalign Technologies, Inc.
CD 70-1089
In Commercial Distribution

  • 00190776094959 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable

IVA Cage - 08809557207885

Cervical Disc Prep Tray
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207885 ()
CD.1000

  • General internal orthopaedic fixation system implantation kit

Counter Sink Drill - 07290109741154

Countersink Drill 3.75X4.20
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109741154 ()
CD 3.75X4.20

  • Fixture/appliance dental drill bit, reusable

Counter Sink Drill - 07290109741161

Countersink Drill 5.0X6.0
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109741161 ()
CD 5.0X6.0

  • Fixture/appliance dental drill bit, reusable

iQ®200 - 10837461002475

iQ®200 Body Fluids Module (CD only)
BECKMAN COULTER IRELAND INC.
Body Fluids Module
In Commercial Distribution

  • 10837461002475 ()
800-3704

  • Laboratory instrument/analyser application software IVD

BioPlex - 03610522207992

BPX Syph Total& RPR Mnl&CD SW4.3 v5
BIO-RAD LABORATORIES, INC.
SW4.3 v5.0
In Commercial Distribution

  • 03610522207992 ()

  • 1 Each
12014549

  • Treponema pallidum total antibody IVD, kit, fluorescent immunoassay

SCHICK - D764B63030001

USBCAM KIT (CAMERA; HOLDER; 25 SHEATHS; DRIVER CD)
SIRONA DENTAL, INC.
B6303000
In Commercial Distribution

  • D764B63030001 ()


  • Diagnostic-imaging photographic film, self-developing

SCHICK - D764B63060001

USBCAM4 KIT (CAMERA; HOLDER; 25 SHEATHS; DRIVER CD)
SIRONA DENTAL, INC.
B6306000
In Commercial Distribution

  • D764B63060001 ()


  • Diagnostic-imaging photographic film, self-developing

BioPlex 2200 - 00847865012607

EBV IgG Assay Protocol File CD, SW4.1_v1, US
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865012607 ()

  • 1 Each
6651270D

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865011006

Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
Not in Commercial Distribution

  • 00847865011006 ()

  • 1 Each
6653870D

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865010986

BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865010986 ()

  • 1 Each
6653270E

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex

BioPlex 2200 - 00847865002240

ToRC IgG Assay Protocol File CD, SW 4_v3
BIO-RAD LABORATORIES, INC.
SW4_V3
In Commercial Distribution

  • 00847865002240 ()

  • 1 Each
6651670G

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

ARCHITECT - 00380740152147

ARCHITECT cSystem SI Units e-Assay CD ROM V15.0
ABBOTT LABORATORIES
4J62-18
In Commercial Distribution

  • 00380740152147 ()
04J6218

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740152130

ARCHITECT cSystem Conv Units e-Assay CD ROM V15.0
ABBOTT LABORATORIES
8G98-18
In Commercial Distribution

  • 00380740152130 ()
08G9818

  • Laboratory instrument/analyser application software IVD

MONO STAN RF FORCEPS - 00841494104009

MONO STAN RF FORCEPS W CABLE & VIDEO CD
Cynosure, LLC
MJ11
In Commercial Distribution

  • 00841494104009 ()
MJ11

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Medline Industries, Inc. - 10888277842151

FCP BIPOLAR 7 1.5 BAY CT CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR10A
In Commercial Distribution

  • 10888277842151 ()
  • 40888277842152 ()
DYNJBIPLR10A

  • General surgical procedure kit, non-medicated, reusable

BOSS Instruments - 00888515228634

Sickle Knife, 7.5mm cd bld, 6 1/2"
BOSS INSTRUMENTS, LTD., INC.
90-3301
In Commercial Distribution

  • 00888515228634 ()
90-3301

  • Ear knife

Boss Babe Body Tampons - 07290016625547

Boss Babe Body Bulk Tampons - 500 CD Super
AL-BAD MASSUOT YITZHAK LTD
BBUSBK500
In Commercial Distribution

  • 07290016625547 ()
  • 07290016625196 ()

  • Absorbency


  • Menstrual tampon, unscented

Boss Babe Body Tampons - 07290016625530

Boss Babe Body Bulk Tampons - 500 CD Regular
AL-BAD MASSUOT YITZHAK LTD
BBURBK500
In Commercial Distribution

  • 07290016625530 ()
  • 07290016625189 ()

  • Absorbency


  • Menstrual tampon, unscented

DETECTABUSE - 00810042684447

STABILITY/QC CONTROL MENU CD, Cutoff 150%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008793
In Commercial Distribution

  • 00810042684447 ()
18008793

  • Multiple drugs of abuse IVD, control

DETECTABUSE - 00810042684430

STABILITY/QC CONTROL MENU CD, Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008792
In Commercial Distribution

  • 00810042684430 ()
18008792

  • Multiple drugs of abuse IVD, control
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