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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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Navina™ Smart App for iOS - 07333387030388

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
In Commercial Distribution

75750

  • Rectal irrigation system application software

Orpheus CAST Mobile App iOS + Android - 07290017025100

A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software

Navina™ Smart App for iOS - 07392532242373

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
Not in Commercial Distribution

  • 07392532242373 ()
75750

  • Rectal irrigation system application software

Lumify Diagnostic Ultrasound System iOS Subscription - 00884838103399

No Description
Philips Ultrasound LLC
795160
In Commercial Distribution

  • 00884838103399 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

DTE - 06944843602189

Curing Light
Guilin Woodpecker Medical Instrument Co., Ltd.
LUX E简约版
In Commercial Distribution

  • 06944843602189 ()


  • Dental/surgical polymerization lamp

ANTI-THYROGLOBULIN TEST KIT (TgAb) - B126KR62750

A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6275
In Commercial Distribution

  • B126KR62750 ()
KR6275

  • Thyroglobulin antibody IVD, kit, radioimmunoassay

ANTI-THYROGLOBULIN TEST KIT (TgAb) - B126KR62700

A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
KRONUS, INC.
KR6270
In Commercial Distribution

  • B126KR62700 ()
KR6270

  • Thyroglobulin antibody IVD, kit, radioimmunoassay

Center Health Blood Glucose Test Strips (50pcs/bot) - 00860003222317

No Description
CENTER HEALTH INCORPORATED
TD-4140
In Commercial Distribution

  • 00860003222317 ()


  • Glucose IVD, kit, electrometry

RPMI 1640 W/GLUT. & GENTAM., 500 ml bot - 00840075401049

No Description
Lonza Walkersville, Inc.
04-1055F
In Commercial Distribution

  • 00840075401049 ()


  • Ex vivo cell culture medium

Solution E LifeCell p/n 131P0063, lL bot - 00840075400363

No Description
Lonza Walkersville, Inc.
04-1135Q
In Commercial Distribution

  • 00840075400363 ()
04-1135Q

  • Ex vivo cell culture medium
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