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510(k) Data Aggregation
K Number
K121134Device Name
TL TRISEB CREAM
Manufacturer
TRIGEN LABORATORIES, INC.
Date Cleared
2012-07-25
(103 days)
Product Code
FRO, DEV
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
TRIGEN LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a healthcare professional, TL Triseb Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. TL Triseb Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Device Description
TL Triseb cream is a non-sterile viscous emulsion/cream formulation. TL Triseb Cream is an off-white, steroid-free, fragrance-free, water-based emulsion.
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K Number
K110762Device Name
AVO BARRIER TOPICAL EMULSION
Manufacturer
TRIGEN LABORATORIES, INC.
Date Cleared
2011-11-18
(245 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
TRIGEN LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AVO Cream Topical Emulsion is indicated for use in:
- Full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers ●
- Superficial wounds
- 1st and 2nd degree burns, including sunburns .
- Dermal donor and graft site management .
- Radiation dermatitis .
- Minor abrasions .
Device Description
AVO Cream Topical Emulsion is a water-based emulsion formulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound, AVO Cream Topical Emulsion provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.
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K Number
K110757Device Name
TL-CERMIDE SKIN BARRIER EMULSION
Manufacturer
TRIGEN LABORATORIES, INC.
Date Cleared
2011-08-19
(154 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
TRIGEN LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TL-Cermide Skin Emulsion is to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. TL-Cermide Skin Emulsion helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Device Description
TL-Cermide Skin Emulsion is a steroid-free, fragrance-free, ceramide-dominant formulation
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