Search Results
Found 2 results
510(k) Data Aggregation
K Number
K161991Device Name
Curasite
Manufacturer
Date Cleared
2017-03-03
(227 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
IZUN PHARMACEUTICALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For Prescription Use Indication:
Under the supervision of a healthcare professional, Curasite is intended for the management of the following:
- Diabetic foot ulcers
- Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
- Pressure ulcers/sores (partial and full thickness)
- 1st and 2nd degree partial thickness burns
For Over-the-Counter Use Indication:
For Over-the-Counter (OTC) use, Curasite may be used for the management of:
- Minor abrasions
- Minor lacerations
- Minor cuts
- Minor scalds and minor burns
Device Description
Not Found
Ask a Question
Ask a specific question about this device
K Number
K103054Device Name
PERIOPATCH
Manufacturer
Date Cleared
2011-02-07
(115 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
IZUN PHARMACEUTICALS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PerioPatch is intended for the management of all types of oral wounds, injuries and ulcerations of the gingiva and oral mucosa, including stomatitis, minor chaffins and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery. PerioPatch operates to relieve pain by adharing to and protecting affected tissues from further irritation, thereby allowing healing.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1