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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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NeoBeat Sys Newborn Heart Rate Meter - 07045432112511

NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
Laerdal Medical AS
532-00001
In Commercial Distribution

  • 07045432112511 ()
532-00001

  • Wearable neonatal heart rate meter

TDA - 03573026099596

TDA is a reagent associated to API 20 E (20 100/20 160), API® 10 S (10 100)
BIOMERIEUX SA
70402
In Commercial Distribution

  • 03573026099596 ()


  • Multiple Enterobacteriaceae species culture isolate identification IVD, reagent

HeadFrame Kit w/20 Short + 20 Long Head Screws - 00858086006306

Contains one 10858086006280 Cranial Screws, Case of 10 Boxes of 2 Short + 2 Long and one 00858086006252 Headframe Kit
VARIAN MEDICAL SYSTEMS, INC.
P1006805005
In Commercial Distribution

  • 00858086006306 ()


  • Stereotactic radiosurgical invasive head frame

Konica Minolta SW Opal (Acquire), 20/20 Opal (Acquire) - 00817100020414

Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-04-01-00-000
In Commercial Distribution

  • 00817100020414 ()


  • Diagnostic x-ray digital imaging system workstation application software

Child Bib Apron With Collar .3mm 20" X 20" - 00812045038784

Child Bib Apron With Collar .3mm Shimmering Green20" X 20"
Flow X Ray Corporation
75053-38
In Commercial Distribution

  • 00812045038784 ()


  • Patient radiation shielding pad/drape, reusable

HCG Pregnancy Serum/Urine Combo Test Cassette (20/20) - 06952804801847

No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801847 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Easy Wipeable Black cover - 00643293015186

Trulife Relax Wheelchair Cover, Relax Easy With Black Cover 20" x 20"
TRULIFE LIMITED
EC004 - 2020
In Commercial Distribution

  • 00643293015186 ()


  • Medical cushion cover

Spex Limited - 09420051789852

Spex Classic Back Support Outer Cover 20"w 20"h (000 Black)
SPEX LIMITED
1255-2020-0SS-C
In Commercial Distribution

  • 09420051789852 ()


  • Wheelchair back rest

Spex Limited - 09420082601208

Constructa Flex Wipedown Cover Only, 20" Wide x 20" Deep, Superhigh Contour
SPEX LIMITED
1102-2020-FSS-W
In Commercial Distribution

  • 09420082601208 ()


  • Wheelchair seat cushion

Spex Limited - 09420082601154

Constructa Shape Wipedown Cover Only, 20" Wide x 20" Deep, Superhigh Contour
SPEX LIMITED
1102-2020-0SS-W
In Commercial Distribution

  • 09420082601154 ()


  • Wheelchair seat cushion
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