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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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Ventilator Non-continuous (Respirator)
Breas Medical AB
US
Not in Commercial Distribution

  • 07321822060168 ()
  • 07321822060007 ()
206000

  • Home CPAP unit
Ventilator Non-continuous (Respirator)
Breas Medical AB
US
Not in Commercial Distribution

  • 07321822050169 ()
  • 07321822050008 ()
205000

  • Home CPAP unit
No Description
Trilliant Surgical, LLC
300-85-012
In Commercial Distribution

  • 00810028395640 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Trilliant Surgical, LLC
300-85-009
In Commercial Distribution

  • 00810028395619 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
BIO CONCEPT Co., Ltd.
031030
In Commercial Distribution

  • 06947600301134 ()


  • Dental implant system
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
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
No Description
Baylis Médicale Cie Inc
PSZ-400-311
Not in Commercial Distribution

  • 00685447001751 ()


  • Arthroscopic surgical procedure kit, non-medicated, single-use
No Description
Biomet Orthopedics, LLC
P3720
In Commercial Distribution

  • 08426750031361 ()
P3720

  • Orthopaedic bone staple, non-adjustable
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
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