FDA.reportPublic FDA data

Stratus Pharmaceuticals, Inc.

Primary DI
00358980780116
Brand
Stratus Pharmaceuticals, Inc.
Company
Stratus Pharmaceuticals, Inc.
Model
780-11
Device description
Venelex 1oz dressing, wound, occlusive
Published
2025-11-10
Public version status
Update
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
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00358980780116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00358980780116003589807801163589807801160358980780116

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
789001641
Device count
1
Premarket exempt
true
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
00358980780215Stratus Pharmaceuticals, Inc.780-212025-11-10
00358980780505Stratus Pharmaceuticals, Inc.780-502025-11-10
00358980960129Stratus Pharmaceuticals, Inc.960-122025-11-10
00358980960204Stratus Pharmaceuticals, Inc.960-202025-11-10
00358980960310Stratus Pharmaceuticals, Inc.960-312025-11-10

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