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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

CARDINAL HEALTH - 10887488564746

KIT, TOTAL KNEE, HILLSDALE COM
Cardinal Health 200, LLC
POW1TKHIM
In Commercial Distribution

  • 50887488564744 ()
  • 10887488564746 ()
POW1TKHIM

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

CARDINAL HEALTH - 10887488551425

KIT,TOTAL KNEE, NORTHWEST COM
Cardinal Health 200, LLC
POCGTKNWL
In Commercial Distribution

  • 50887488551423 ()
  • 10887488551425 ()
POCGTKNWL

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

SpO2.COM® NRC-GE Patient Cable - 00843997001397

SpO2.COM NRC-GE Patient Cable
MASIMO CORPORATION
1854
In Commercial Distribution

  • 00843997001397 ()
1854

  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-395 Patient Cable - 00843997001366

SpO2.COM NRC-395 Patient Cable
MASIMO CORPORATION
1811
In Commercial Distribution

  • 00843997001366 ()
1811

  • Electrical-only medical device connection cable, reusable

Medline Industries, Inc. - 10193489391145

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585A
In Commercial Distribution

  • 40193489391146 ()
  • 10193489391145 ()
DYNJ60585A

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

NAMIC - 10193489075182

3,PORT,KIT,COM HOSP
MEDLINE INDUSTRIES, INC.
650311521
In Commercial Distribution

  • 10193489075182 ()
  • 20193489075189 ()
650311521

  • Angiography kit

CARDINAL HEALTH - 10888439513165

KIT,TOTAL KNEE, NORTHWEST COM
Cardinal Health 200, LLC
POCGTKNWM
In Commercial Distribution

  • 50888439513163 ()
  • 10888439513165 ()
POCGTKNWM

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

Medline Industries, Inc. - 10193489986297

3 PORT KIT COM HOSP
MEDLINE INDUSTRIES, INC.
650311521
In Commercial Distribution

  • 40193489986298 ()
  • 10193489986297 ()
650311521

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

Medline Industries, Inc. - 10193489523652

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585
In Commercial Distribution

  • 10193489523652 ()
DYNJ60585

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

Supremo Instrumentos - 07908854000890

Broca Coletora com Capa 7.0
ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
S7923
In Commercial Distribution

  • 07908854000890 ()


  • Surgical screwdriver, reusable

NORDENT MANUFACTURING INC - 00840018636057

SPECIAL COM PLACM PER MICRODEN
NORDENT MANUFACTURING INC
PFICOMP14
In Commercial Distribution

  • 00840018636057 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635401

COM PLACEM INSTDE, #37, DL-RND
NORDENT MANUFACTURING INC
REPFI37
In Commercial Distribution

  • 00840018635401 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635746

COM PLACEMENT INST DE WOODSN #
NORDENT MANUFACTURING INC
CEPFIW1
In Commercial Distribution

  • 00840018635746 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018635548

COM PLACEMENT INST DE WOODSN #
NORDENT MANUFACTURING INC
REPFIW1
In Commercial Distribution

  • 00840018635548 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018634961

COM PLACEMENT INST DE - HOE
NORDENT MANUFACTURING INC
PFI4A-MT40
In Commercial Distribution

  • 00840018634961 ()


  • Margin finishing dental file/rasp, reusable

Easy III - 00840067100622

Easy III Power Com Module
CADWELL INDUSTRIES, INC.
190245-200
In Commercial Distribution

  • 00840067100622 ()


  • Electroencephalograph

Cascade Elite - 00840067100295

Cascade Elite Power/Com Module
CADWELL INDUSTRIES, INC.
190240-200
In Commercial Distribution

  • 00840067100295 ()


  • Neurophysiologic monitoring system

Brasseler USA - 00887919801467

K0354 MCLAREN UAB COM/BISACRYL
Peter Brasseler Holdings, LLC
5026493U0
In Commercial Distribution

  • 00887919801467 ()


  • Diamond dental bur, single-use

Medline Industries, Inc. - 10195327605544

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585C
In Commercial Distribution

  • 40195327605545 ()
  • 10195327605544 ()
DYNJ60585C

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

Medline Industries, Inc. - 10195327547776

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585B
In Commercial Distribution

  • 40195327547777 ()
  • 10195327547776 ()
DYNJ60585B

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

Unimed - 06945664856577

Reusable Thermometer Probe/20K/Adult/Skin/LP2单公/1.6M/郑州迪生
Unimed Medical Supplies, Inc.
TDS-16AS
In Commercial Distribution

  • 06945664856577 ()


  • General-purpose patient temperature probe, reusable

NA - 04546540670069

T4 Charger Module
STRYKER CORPORATION
0400655003
In Commercial Distribution

  • 04546540670069 ()
0400655003

  • Surgical helmet system

A.L.P.S. mvX™ - 00196449016808

T4 RETENTION DRIVER
Tyber Medical LLC
770001040
In Commercial Distribution

  • 00196449016808 ()
770001040

  • Surgical screwdriver, reusable

NA - 04546540152534

T4 Power Pack
STRYKER CORPORATION
0400650000
In Commercial Distribution

  • 04546540152534 ()
0400650000

  • Surgical helmet system

Shukla Mini S9MINI - B756SDR2160

Driver, Torx, T4
Shukla Medical
SDR216
In Commercial Distribution

  • B756SDR2160 ()


  • Surgical screwdriver, reusable

Headless Screw System Instruments - M6950010000090

T4 (Solid) Torx
Tyber Medical LLC
001-000009
Not in Commercial Distribution

  • M6950010000090 ()
001-000009

  • Orthopaedic implant driver

Baebies 6-HMU Dilution Set - 00819704020289

6-HMU Dilution Set General Purpose Reagent, For Laboratory Use.
BAEBIES, INC.
2110
In Commercial Distribution

  • 00819704020289 ()
  • 10819704020286 ()
2110

  • Newborn metabolic screen/congenital disorder IVD, calibrator

SEEKER™ - 00819704020227

SEEKER™ Quality Control Dried Blood Spot Kit Contains 5 levels: QC Base Pool, QC Low, QC Intermediate, QC Medium, and QC High
BAEBIES, INC.
3416
In Commercial Distribution

  • 00819704020227 ()
3416

  • Newborn metabolic screen/congenital disorder IVD, control

Baebies - 00819704020210

Quality Control Dried Blood Spot - Intermediate
BAEBIES, INC.
3369
In Commercial Distribution

  • 00819704020210 ()
3369

  • Newborn metabolic screen/congenital disorder IVD, control

SEEKER™ - 00819704020159

SEEKER™ Calibrant D
BAEBIES, INC.
2131
In Commercial Distribution

  • 00819704020159 ()
2131

  • Newborn metabolic screen/congenital disorder IVD, calibrator

SEEKER™ - 00819704020142

SEEKER™ Calibrant C
BAEBIES, INC.
2130
In Commercial Distribution

  • 00819704020142 ()
2130

  • Newborn metabolic screen/congenital disorder IVD, calibrator

SEEKER™ - 00819704020135

SEEKER™ Calibrant B
BAEBIES, INC.
2129
In Commercial Distribution

  • 00819704020135 ()
2129

  • Newborn metabolic screen/congenital disorder IVD, calibrator

SEEKER™ - 00819704020128

SEEKER™ Calibrant A
BAEBIES, INC.
2128
In Commercial Distribution

  • 00819704020128 ()
2128

  • Newborn metabolic screen/congenital disorder IVD, calibrator

Baebies - 00819704020067

Quality Control Dried Blood Spot - High
BAEBIES, INC.
0977
In Commercial Distribution

  • 00819704020067 ()
0977

  • Newborn metabolic screen/congenital disorder IVD, control

Baebies - 00819704020050

Quality Control Dried Blood Spot - Medium
BAEBIES, INC.
0976
In Commercial Distribution

  • 00819704020050 ()
0976

  • Newborn metabolic screen/congenital disorder IVD, control

Baebies - 00819704020043

Quality Control Dried Blood Spot - Low
BAEBIES, INC.
0975
In Commercial Distribution

  • 00819704020043 ()
0975

  • Newborn metabolic screen/congenital disorder IVD, control

Baebies - 00819704020036

Quality Control Dried Blood Spot - Base Pool
BAEBIES, INC.
0974
In Commercial Distribution

  • 00819704020036 ()
0974

  • Newborn metabolic screen/congenital disorder IVD, control

Dried Blood Control - 04250317502865

MassCheck® Amino Acids, Acylcarnitines inc. Succinylacetone, Dried Blood Spot Control Level II
Chromsystems Instruments + Chemicals GmbH
0193
In Commercial Distribution

  • 04250317502865 ()

  • 1 x 3spots
0193

  • Newborn metabolic screen/congenital disorder IVD, control

Dried Blood Control - 04250317502841

MassCheck® Amino Acids, Acylcarnitines inc. Succinylacetone, Dried Blood Spot Control Level I
Chromsystems Instruments + Chemicals GmbH
0192
In Commercial Distribution

  • 04250317502841 ()

  • 1 x 3spots
0192

  • Newborn metabolic screen/congenital disorder IVD, control

Dried Blood Control Bi-Level - 04250317502834

MassCheck® Amino Acids, Acylcarnitines inc. Succinylacetone, Dried Blood Spot Control Bi-Level
Chromsystems Instruments + Chemicals GmbH
0191
In Commercial Distribution

  • 04250317502834 ()

  • 2 x 3 spots
0191

  • Newborn metabolic screen/congenital disorder IVD, control

NAMIC - 10193489051001

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

  • 20193489051008 ()
  • 10193489051001 ()
60193165

  • Angiography kit

NAMIC - 10193489050639

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

  • 20193489050636 ()
  • 10193489050639 ()
60190792

  • Angiography kit

NAMIC - 10193489043488

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

  • 20193489043485 ()
  • 10193489043488 ()
60052241

  • Angiography kit

NAMIC - 10193489049909

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

  • 20193489049906 ()
  • 10193489049909 ()
60183101

  • Angiography kit

NAMIC - 10193489047516

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

  • 20193489047513 ()
  • 10193489047516 ()
60137612

  • 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

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
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