FDA.reportPublic FDA data

Asclepii Poseidon Nanosilver Hydrogel OTC 3oz

Primary DI
00735549200733
Brand
Asclepii Poseidon Nanosilver Hydrogel OTC 3oz
Company
Asclepii Inc.
Model
1100073
Device description
Nanosilver Hydrogel Clear wound dressing for topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations
Published
2025-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K131176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131176000ROSS RU SKIN DISCONTINUITIESBiotd S.A.2014-05-12FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00735549200733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00735549200733007355492007337355492007330735549200733

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+50622721015hrodriguez@labzepol.com

Regulatory Flags#

DUNS number
118862618
Device count
1
Combination product
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
00735549200740Asclepii Poseidon Nanosilver Hydrogel Rx 1oz11000742025-12-04
00735549200726Asclepii Poseidon Nanosilver Hydrogel OTC 1 oz11000722025-12-04
00735549200757Asclepii Poseidon Nanosilver Hydrogel Rx 3 oz11000752025-12-04

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Primary DI, Brand, Company table
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