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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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N/A - 00613994120557

CASE 6957206L VRTX MX CNN PT SCRW CDDY
MEDTRONIC SOFAMOR DANEK, INC.
6957206L
In Commercial Distribution

  • 00613994120557 ()


  • Instrument tray, reusable

VERTEX® Reconstruction System - 00613994120540

CASE 6957206 VRTX MX CNN 4.0MM PT SCRW
MEDTRONIC SOFAMOR DANEK, INC.
6957206
In Commercial Distribution

  • 00613994120540 ()


  • Instrument tray, reusable

N/A - 00613994120533

CASE 6957205L VRTX MX CNN 4.5MM SCRW CDY
MEDTRONIC SOFAMOR DANEK, INC.
6957205L
In Commercial Distribution

  • 00613994120533 ()


  • Instrument tray, reusable

VERTEX® Reconstruction System - 00613994120526

CASE 6957205 VRTX MX CNN 4.5MM SCRW CDDY
MEDTRONIC SOFAMOR DANEK, INC.
6957205
In Commercial Distribution

  • 00613994120526 ()


  • Instrument tray, reusable

N/A - 00613994120519

CASE 6957204L VRTX MX CNN 4.0MM SCRW CDY
MEDTRONIC SOFAMOR DANEK, INC.
6957204L
In Commercial Distribution

  • 00613994120519 ()


  • Instrument tray, reusable

VERTEX® Reconstruction System - 00613994120502

CASE 6957204 VRTX MX CNN 4.0MM SCRW CDDY
MEDTRONIC SOFAMOR DANEK, INC.
6957204
In Commercial Distribution

  • 00613994120502 ()


  • Instrument tray, reusable

N/A - 00613994120465

CASE 6957202 VRTX MX CANN IMPLNT OUTR CS
MEDTRONIC SOFAMOR DANEK, INC.
6957202
In Commercial Distribution

  • 00613994120465 ()


  • Instrument tray, reusable

N/A - 00613994117106

CASE 8889242R TSRH SILO SAS TRAY 2 TI
MEDTRONIC SOFAMOR DANEK, INC.
8889242R
In Commercial Distribution

  • 00613994117106 ()


  • Instrument tray, reusable

N/A - 00613994116956

CASE 8359105 TSRH TC DEG INSTR TRAY 1
MEDTRONIC SOFAMOR DANEK, INC.
8359105
Not in Commercial Distribution

  • 00613994116956 ()


  • Instrument tray, reusable

N/A - 00613994116925

CASE 8359102 TSRH TC DEG TI IMPL TRAY
MEDTRONIC SOFAMOR DANEK, INC.
8359102
Not in Commercial Distribution

  • 00613994116925 ()


  • Instrument tray, reusable

N/A - 00613994111913

CASE 7050420L 5.5 INS TRAY LID TLIF DIST
MEDTRONIC SOFAMOR DANEK, INC.
7050420L
In Commercial Distribution

  • 00613994111913 ()


  • Instrument tray, reusable

N/A - 00840329812294

INSTRUMENT CASE, SS, 24CM X 26CM X 2.5CM
BLACK & BLACK SURGICAL, INC.
B3C-4011
In Commercial Distribution

  • 00840329812294 ()
B3C-4011

  • Instrument tray, reusable

Protective Cap - 10816203021707

Protective Cap for female luer, case of 50
ORIGEN BIOMEDICAL, INC.
PC2-B
Not in Commercial Distribution

  • 20816203021704 ()
  • 10816203021707 ()


  • Blood transfer set

Evolve - 10816203021592

Evolve Tissue Culture Bag, 120ml, case of 20
ORIGEN BIOMEDICAL, INC.
EV120
Not in Commercial Distribution

  • 10816203021592 ()
  • 20816203021599 ()


  • Blood/tissue storage/culture container

OIC Intramedullary Nail System - 10811998036530

STERILIZATION CASE IM NAIL LONG HIP NAILS TRAY
ORTHOPAEDIC IMPLANT COMPANY, THE
01-IM55
In Commercial Distribution

  • 10811998036530 ()


  • Device sterilization/disinfection container, reusable

Safco Daily Plus Bibs - 10810063752375

Safco Daily Plus bibs Light Blue, 500/case
SAFCO DENTAL SUPPLY CO.
1020057
In Commercial Distribution

  • 00810063752378 ()
  • 10810063752375 ()
1020057

  • Dental bib

Vermed Holter Kit - 10813150020487

Packed for Global Instrumentation 50 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
000-400-0061
Not in Commercial Distribution

  • 10813150020487 ()
  • 00813150020480 ()
000-400-0061

  • Electrocardiographic long-term ambulatory recording support kit

Vermed Holter Kit - 10813150020456

Packed for Global Instrumentation 50 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
000-400-0060
Not in Commercial Distribution

  • 10813150020456 ()
  • 00813150020459 ()
000-400-0060

  • Electrocardiographic long-term ambulatory recording support kit

Cortera Spinal Fixation System - 00840311252190

Case ASM, IMP, Rod, CoCr HY, PB, 5.5
Xtant Medical Holdings, Inc.
1509-200200
In Commercial Distribution

  • 00840311252190 ()


  • Instrument tray, reusable

OIC Intramedullary Nail System - 10811998036523

STERILIZATION CASE IM NAIL HIP AND FEMUR TRAY
ORTHOPAEDIC IMPLANT COMPANY, THE
01-IM54
In Commercial Distribution

  • 10811998036523 ()


  • Device sterilization/disinfection container, reusable

JMU - 00840456214930

JMU 3" Cotton Tipped Applicator, 10boxes(100bags)/case
JMU DENTAL, INC
20611005
In Commercial Distribution

  • 00840456214930 ()


  • General-purpose absorbent tip applicator/swab, single-use

Virtuox - 10817698020220

Nonin compatible neonatal disposable probes, case of 24
HEALTHCARE LOGISTICS SYSTEMS LLC
1803
In Commercial Distribution

  • 10817698020220 ()
  • 00817698020223 ()


  • Pulse oximeter probe, single-use

Virtuox - 10817698020213

Nonin compatible infant disposable probes, case of 24
HEALTHCARE LOGISTICS SYSTEMS LLC
1802
In Commercial Distribution

  • 10817698020213 ()
  • 00817698020216 ()


  • Pulse oximeter probe, single-use

Virtuox - 10817698020190

Nonin compatible adult disposable probes, case of 24
HEALTHCARE LOGISTICS SYSTEMS LLC
1800
In Commercial Distribution

  • 10817698020190 ()
  • 00817698020193 ()


  • Pulse oximeter probe, single-use

Virtuox - 10817698020312

Nellcor Compatible, neonatal disposable probes, case of 24
HEALTHCARE LOGISTICS SYSTEMS LLC
1900
In Commercial Distribution

  • 10817698020312 ()
  • 00817698020315 ()


  • Pulse oximeter probe, single-use

Virtuox - 10817698020206

Nonin compatible pediatric disposable probes, case of 24
HEALTHCARE LOGISTICS SYSTEMS LLC
1801
In Commercial Distribution

  • 10817698020206 ()
  • 00817698020209 ()


  • Pulse oximeter probe, single-use

L.M.C Associates, Inc. - 10813150022467

Stress and Holter Electrode 60/POUCH, 600 /CASE
GRAPHIC CONTROLS ACQUISITION CORP
LMC 404
In Commercial Distribution

  • 20813150022464 ()
  • 10813150022467 ()
  • 00813150022460 ()
LMC 404

  • Electrocardiographic electrode, single-use

Jaken Resting Tab Electrodes - 10813150022245

100/pouch, 1,000 per box, 4000 per case
GRAPHIC CONTROLS ACQUISITION CORP
E-5253
Not in Commercial Distribution

  • 10813150022245 ()
  • 00813150022248 ()
E-5253

  • Electrocardiographic electrode, single-use

Vermed Holter Kit - 10813150022016

Packed for: Altura Medical 50 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
KIT-ALT2
In Commercial Distribution

  • 10813150022016 ()
  • 00813150022019 ()
KIT-ALT2

  • Electrocardiographic long-term ambulatory recording support kit

Vermed Holter Kit - 10813150021903

Packed for: Med Monitoring-LLC 50 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
KIT-MED37A
In Commercial Distribution

  • 10813150021903 ()
  • 00813150021906 ()
KIT-MED37A

  • Electrocardiographic long-term ambulatory recording support kit

Vermed Holter Kit - 10813150021842

Packed for: Med Monitoring 50 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
K-MED CD7AA
Not in Commercial Distribution

  • 10813150021842 ()
  • 00813150021845 ()
K-MED CD7AA

  • Electrocardiographic long-term ambulatory recording support kit

Vermed Holter Kit - 10813150021835

Packed for J.L. Marketing 50 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
K-JLM3
In Commercial Distribution

  • 10813150021835 ()
  • 00813150021838 ()
K-JLM3

  • Electrocardiographic long-term ambulatory recording support kit

Vermed Holter Kit - 10813150021828

Packed for J.L. Marketing 50 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
K-JLM2
In Commercial Distribution

  • 10813150021828 ()
  • 00813150021821 ()
K-JLM2

  • Electrocardiographic long-term ambulatory recording support kit

Vermed Holter Kit - 10813150021811

Packed for: Vantage Medical 50 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
KIT-VAN
In Commercial Distribution

  • 10813150021811 ()
  • 00813150021814 ()
KIT-VAN

  • Electrocardiographic long-term ambulatory recording support kit

Vermed Holter Kit - 10813150021569

Packed for: Med Monitoring-LLC 50 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
KIT-MED35A
In Commercial Distribution

  • 10813150021569 ()
  • 00813150021562 ()
KIT-MED35A

  • Electrocardiographic long-term ambulatory recording support kit

Vermed Holter Kit - 10813150021347

Packed for E-Research Technology 25 KITS PER CASE
GRAPHIC CONTROLS ACQUISITION CORP
ERES01-1
In Commercial Distribution

  • 10813150021347 ()
  • 00813150021340 ()
ERES01-1

  • Electrocardiographic long-term ambulatory recording support kit

Marina Medical - 00840306828287

Electrode Sterilizing Case: 2.5in x 6in x .75in
MARINA MEDICAL INSTRUMENTS, INC.
300-205
In Commercial Distribution

  • 00840306828287 ()

  • Length: 6 Inch
300-205

  • Surgical tray stand

Jet-X - 03596010608086

JET-X AUXILLARY INSTRUMENT MODULE STERILIZATION CASE WITH LID
Smith & Nephew, Inc.
71067354
In Commercial Distribution

  • 03596010608086 ()
71067354

  • Device sterilization/disinfection container, reusable

Jet-X - 03596010608079

JET-X HALF PIN MODULE STERILIZATION CASE WITH LID
Smith & Nephew, Inc.
71067360
In Commercial Distribution

  • 03596010608079 ()
71067360

  • Device sterilization/disinfection container, reusable

HemoWeld-Gun - 08033928530139

Portable sealer for blood bag tubes - Case Kit
DELCON SRL
HWG2.00V
In Commercial Distribution

  • 08033928530139 ()


  • Blood donor bag tube divider/sealer
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