FDA.reportPublic FDA data

Asclepii Poseidon Nanosilver Hydrogel OTC 1 oz

Primary DI
00735549200726
Brand
Asclepii Poseidon Nanosilver Hydrogel OTC 1 oz
Company
Asclepii Inc.
Model
1100072
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
00735549200726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00735549200726007355492007267355492007260735549200726

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
00735549200733Asclepii Poseidon Nanosilver Hydrogel OTC 3oz11000732025-12-04
00735549200757Asclepii Poseidon Nanosilver Hydrogel Rx 3 oz11000752025-12-04

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Primary DI, Brand, Company table
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