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Found 6 results
510(k) Data Aggregation
K Number
K003734Device Name
SERUM PROTEIN SUBSTITUTE
Manufacturer
SAGE BIOPHARMA
Date Cleared
2000-12-21
(17 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
SAGE BIOPHARMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002836Device Name
MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE
Manufacturer
SAGE BIOPHARMA
Date Cleared
2000-10-03
(21 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
SAGE BIOPHARMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991396Device Name
WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L
Manufacturer
SAGE BIOPHARMA
Date Cleared
2000-02-15
(300 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
SAGE BIOPHARMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Water for Tissue Culture is to be used for tissue culture in assisted reproduction procedures.
Device Description
Water for Tissue Culture 500mL
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K Number
K991393Device Name
HYALURONIDASE, 80 U/ML
Manufacturer
SAGE BIOPHARMA
Date Cleared
2000-02-02
(287 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
SAGE BIOPHARMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hyaluronidase is used prior to intracytoplasmic sperm injections (ICSI) procedures to digest the hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.
Device Description
Not Found
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K Number
K991390Device Name
1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI
Manufacturer
SAGE BIOPHARMA
Date Cleared
2000-01-18
(272 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
SAGE BIOPHARMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cryopreservation Media is used for assisted reproduction procedures, for the purposes of preparation of the human embryos for cryopreservation. They are used during the cryopreservation process of preserving embryos, both for freezing and thawing during assisted reproduction procedures.
Device Description
Cryopreservation Media
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K Number
K991378Device Name
PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED
Manufacturer
SAGE BIOPHARMA
Date Cleared
1999-09-24
(156 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
SAGE BIOPHARMA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Phosphate Buffered Saline (PBS) and Phosphate Buffered Saline, with calcium, magnesium, glucose, pyruvate and phenol red are for in vitro procedures involving the manipulations of gametes and embryos such as oocyte retrieval or embryo transfer, gamete washing, or micromanipulation. They may also be used for cryopreservation of qametes and embryos after the addition of appropriate cryopreservation agent(s).
Device Description
Phosphate Buffered Saline (PBS) and PBS with calcium, magnesium, glucose, pyruvate and phenol red Medium
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