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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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TCmatt - 04260647540031

Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns and infants.
Tec Com Medizintechnik GmbH
NEOmulti
In Commercial Distribution

  • 04260647540031 ()
6426801

  • External circulating-fluid core temperature regulation system pad, reusable

TCmatt - 04260647540017

Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns and infants.
Tec Com Medizintechnik GmbH
NEOsingle
In Commercial Distribution

  • 04260647540017 ()
  • 04260647540116 ()
6427401

  • External circulating-fluid core temperature regulation system pad, single-use

Skater™ Biliary Drainage Catheter Non-Locking Non-Locking - 00886333006106

Skater™ Biliary Drainage Catheter Non-Locking Non-Locking with Radiopaque Band(12Fr x 40 cm)
ARGON MEDICAL DEVICES, INC.
12Fr x 40 cm
In Commercial Distribution

  • 20886333006100 ()
  • 00886333006106 ()

  • 12 F x 40 com
755212040

  • Biliary drain

NAMIC - 10193489047516

MTS LEFT HEART KIT-MEDINA COM HOSP
MEDLINE INDUSTRIES, INC.
60137612
In Commercial Distribution

  • 20193489047513 ()
  • 10193489047516 ()
60137612

  • Angiography kit

NAMIC - 10193489043488

MTS LEFT HEART KIT EVANGELICAL COM
MEDLINE INDUSTRIES, INC.
60052241
In Commercial Distribution

  • 20193489043485 ()
  • 10193489043488 ()
60052241

  • Angiography kit

NAMIC - 10193489050639

MTO LEFT HEART COM HOSP-SAN BERNARDINO
MEDLINE INDUSTRIES, INC.
60190792
In Commercial Distribution

  • 20193489050636 ()
  • 10193489050639 ()
60190792

  • Angiography kit

NAMIC - 10193489051001

MTS LEFT HEART KIT-SOMERSET COM HOSP
MEDLINE INDUSTRIES, INC.
60193165
In Commercial Distribution

  • 20193489051008 ()
  • 10193489051001 ()
60193165

  • Angiography kit

NAMIC - 10193489049909

MTS LEFT HEART KIT-HENDRICKS COM HOSP
MEDLINE INDUSTRIES, INC.
60183101
In Commercial Distribution

  • 20193489049906 ()
  • 10193489049909 ()
60183101

  • Angiography kit

CoreValve™ - 00643169565630

DEL SYS DCS-C4-18F-23US COM 23 NP
MEDTRONIC COREVALVE LLC
DCS-C4-18F-23US
Not in Commercial Distribution

  • 00643169565630 ()

  • Valve Size 23 MM


  • Aortic transcatheter heart valve bioprosthesis, stent-like framework

PILLING - 14026704916846

NG OSSOFF-KARLAN POST COM LASER SCOPE
TELEFLEX INCORPORATED
IPN928144
In Commercial Distribution

  • 24026704916843 ()
  • 14026704916846 ()
532233S

  • Rigid optical laryngopharyngoscope

PILLING - 14026704916778

NG OSSOFF-KARLAN POST COM LASER LAR
TELEFLEX INCORPORATED
IPN928136
In Commercial Distribution

  • 24026704916775 ()
  • 14026704916778 ()
532233

  • Rigid optical laryngopharyngoscope

Marina Medical - 00840306822070

Walton Com Extr,w/o lancet"
MARINA MEDICAL INSTRUMENTS, INC.
190-157C
In Commercial Distribution

  • 00840306822070 ()
190-157C

  • Comedo expressor

NORDENT MANUFACTURING INC - 00840018647015

COM PLACM INST DE #7 DL-R
NORDENT MANUFACTURING INC
REPFI7
In Commercial Distribution

  • 00840018647015 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018637979

COM PLACMENT INST. 41T DL-CC H
NORDENT MANUFACTURING INC
CEPFI41T
In Commercial Distribution

  • 00840018637979 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018637573

COM PLACEM INSTDE, #38 TIN, DL
NORDENT MANUFACTURING INC
REPFI38T
In Commercial Distribution

  • 00840018637573 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018637566

COM PLACEM INSTDE, #37 TIN, DL
NORDENT MANUFACTURING INC
REPFI37T
In Commercial Distribution

  • 00840018637566 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636651

COM PLACEMENT INST, #41 TiN, R
NORDENT MANUFACTURING INC
REPFI41T
In Commercial Distribution

  • 00840018636651 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636644

COM PLACEM INSTDE, #40 TIN, DL
NORDENT MANUFACTURING INC
REPFI40T
In Commercial Distribution

  • 00840018636644 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636583

COM PLACEM INSTDE, #39 TIN, DL
NORDENT MANUFACTURING INC
REPFI39T
In Commercial Distribution

  • 00840018636583 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636538

COM PLACEM INSTDE, #32 TIN, DL
NORDENT MANUFACTURING INC
REPFI32T
In Commercial Distribution

  • 00840018636538 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636453

COM PLACEM INSTDE, #29 TIN, DL
NORDENT MANUFACTURING INC
REPFI29T
In Commercial Distribution

  • 00840018636453 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018636439

COM PLACEM INSTDE, #28 TIN, DL
NORDENT MANUFACTURING INC
REPFI28T
In Commercial Distribution

  • 00840018636439 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635951

COM PLACEM INSTDE, #40 TIN, ST
NORDENT MANUFACTURING INC
PFI40T
In Commercial Distribution

  • 00840018635951 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635838

COM PLACM INSDE #21 TIN REG
NORDENT MANUFACTURING INC
PFI21T
In Commercial Distribution

  • 00840018635838 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635821

COM PLACM INSDE #20 TIN REG
NORDENT MANUFACTURING INC
PFI20T
In Commercial Distribution

  • 00840018635821 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635098

COM PLACM INST DE FELTS #6
NORDENT MANUFACTURING INC
PFIF6
In Commercial Distribution

  • 00840018635098 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635081

COM PLACM INST DE FELTS #5
NORDENT MANUFACTURING INC
PFIF5
In Commercial Distribution

  • 00840018635081 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635074

COM PLACM INST DE FELTS #4
NORDENT MANUFACTURING INC
PFIF4
In Commercial Distribution

  • 00840018635074 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635067

COM PLACM INST DE FELTS #3
NORDENT MANUFACTURING INC
PFIF3
In Commercial Distribution

  • 00840018635067 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635050

COM PLACM INST DE FELTS #2
NORDENT MANUFACTURING INC
PFIF2
In Commercial Distribution

  • 00840018635050 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635043

COM PLACM INST DE FELTS #1
NORDENT MANUFACTURING INC
PFIF1
In Commercial Distribution

  • 00840018635043 ()


  • Margin finishing dental file/rasp, reusable

SCHWERT - E89614071240

Bone curettes MOLT 2/4 COM
A. Schweickhardt GmbH & Co. KG
1407-124
In Commercial Distribution

  • E89614071240 ()
1407-124

  • Periosteal elevator, reusable

Brasseler USA - 00887919744924

UNIV BUFFALO YR1 COM/AMA REFILL
Peter Brasseler Holdings, LLC
5025256U0
In Commercial Distribution

  • 00887919744924 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919971399

K0434 PASCAL MAGNE COM/CER FIN
Peter Brasseler Holdings, LLC
5031007U0
In Commercial Distribution

  • 00887919971399 ()


  • Dental abrasive point, reusable

INTENSA - M368IN597GCOM1

RECL OB II ARM CAP COM
GF HEALTH PRODUCTS, INC.
IN597GCOM
In Commercial Distribution

  • M368IN597GCOM1 ()


  • Reclining chair

First Check - 00643281061553

First Check Home Drug Test One Drug Marijuana
FIRST CHECK DIAGNOSTIC CORP.
One Drug Marijuana
Not in Commercial Distribution

  • 00643281061553 ()
THC

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

NAMIC - 10193489042467

MTO LEFT HEART KIT CENTRAL MICHIGAN COM
MEDLINE INDUSTRIES, INC.
60033151
In Commercial Distribution

  • 20193489042464 ()
  • 10193489042467 ()
60033151

  • Angiography kit

NAMIC - 10193489041927

MTO SINGLE MONING KIT BOULDER COM HOSP
MEDLINE INDUSTRIES, INC.
60030544
In Commercial Distribution

  • 20193489041924 ()
  • 10193489041927 ()
60030544

  • Angiography kit

NAMIC - 10193489075120

MTO PICC/ANGIO SYRINGE KIT BOULDER COM
MEDLINE INDUSTRIES, INC.
650305410
In Commercial Distribution

  • 10193489075120 ()
650305410

  • Angiography kit

NAMIC - 10193489060232

DBD-MTO ANGIO KIT COM HOSP ANDERSON PG
MEDLINE INDUSTRIES, INC.
65031863
In Commercial Distribution

  • 10193489060232 ()
65031863

  • Angiography kit
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