FDA.reportPublic FDA data

Stratus Pharmaceuticals, Inc.

Primary DI
00358980960204
Brand
Stratus Pharmaceuticals, Inc.
Company
Stratus Pharmaceuticals, Inc.
Model
960-20
Device description
Sonafine Dressing, wound, drug Topical Emulsion 5gm/20. SonaFine is registered as Dressing Wound Drug werein the drug is a preservative. SonaFine is not promoted as an antibacterial or antimicrobial dressing. It is not promoted to treat infected wounds.
Published
2025-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110172000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110172000SONAFINE WOUND DRESSINGStratus Pharmaceutical2011-08-19FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00358980960204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00358980960204003589809602043589809602040358980960204

GMDN Terms#

Term, Definition table
TermDefinition
Skin semi-occlusive dressing, non-antimicrobialA substance (e.g., gel, ointment) intended to be topically applied to injured/diseased skin to expedite healing and re-epithelialization primarily through semi-occlusive properties which reduce moisture transmission from the skin to the environment by means of a physical barrier; it may also prevent abnormal scar formation and does not include an antimicrobial agent(s). It is intended for home/healthcare facility use to treat open skin wounds and/or conditions such as lacerations, burns, surgical wounds, radiation dermatitis, and inflammation. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Regulatory Flags#

DUNS number
789001641
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00358980780116Stratus Pharmaceuticals, Inc.780-112025-11-10
00358980780215Stratus Pharmaceuticals, Inc.780-212025-11-10
00358980780505Stratus Pharmaceuticals, Inc.780-502025-11-10
00358980960129Stratus Pharmaceuticals, Inc.960-122025-11-10
00358980960310Stratus Pharmaceuticals, Inc.960-312025-11-10

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Primary DI, Brand, Company table
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00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29