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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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ASSY-LPCR+,SEMI,CIRCULATION PROMPT,200-300-360
PHYSIO-CONTROL, INC.
97403
In Commercial Distribution

97403-000013

  • Rechargeable public semi-automated external defibrillator
ASSY-LP CR PLUS.AUTO,CIRCULATION
PHYSIO-CONTROL, INC.
97403
In Commercial Distribution

97403-000005

  • Rechargeable public automated external defibrillator
ASSY-LP CR PLUS, AUTO,BREATHING
PHYSIO-CONTROL, INC.
97403
In Commercial Distribution

97403-000003

  • Rechargeable public automated external defibrillator
ASSY-LP CR PLUS,SEMI,CHECK FOR BREATHING
PHYSIO-CONTROL, INC.
97403
In Commercial Distribution

97403-000006

  • Rechargeable public semi-automated external defibrillator
ASSY-LP CR PLUS, AUTO,PULSE
PHYSIO-CONTROL, INC.
97403
In Commercial Distribution

97403-000002

  • Rechargeable public automated external defibrillator
ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology. The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.
PROGENIKA BIOPHARMA, SA
v3
In Commercial Distribution

  • 08437013457019 ()
1021720000

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)
ISPAN C3F8 PERFLUOROPROPANE ISPAN* C3F8 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 8,600. Residual ISPAN* C3F8 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances.
Alcon Laboratories, Inc.
8065797103
Not in Commercial Distribution

  • 00380657971039 ()

  • Weight: 25 Gram


  • Vitreous/aqueous humour replacement medium, intraoperative
ISPAN C3F8 PERFLUOROPROPANE ISPAN* C3F8 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 8,600. Residual ISPAN* C3F8 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances.
Alcon Laboratories, Inc.
8065797102
In Commercial Distribution

  • 00380657971022 ()

  • Weight: 125 Gram


  • Vitreous/aqueous humour replacement medium, intraoperative
ISPAN C3F8 PERFLUOROPROPANE ISPAN* C3F8 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 8,600. Residual ISPAN* C3F8 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances.
Alcon Laboratories, Inc.
8065797101
Not in Commercial Distribution

  • 00380657971015 ()

  • Weight: 450 Gram


  • Vitreous/aqueous humour replacement medium, intraoperative
Adherus AutoSpray Extended Tip (ET) Dural Sealant is a sterile, single-use, electromechanical, battery operated device with internal system components that provide air flow to aid in the delivery of a synthetic, absorbable, two-component hydrogel sealant system and allow delivery to be interrupted without clogging.
HYPERBRANCH MEDICAL TECHNOLOGY, INC.
NUS-109
In Commercial Distribution

  • 30897146002026 ()
  • 00897146002025 ()


  • Dura mater sealant
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