FDA UDI
In Commercial Distribution
🇺🇸 United States
Asclepii Poseidon Nanosilver Hydrogel Rx 3 oz
DI: 00735549200757
·
Model: 1100075
·
Asclepii Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Asclepii Poseidon Nanosilver Hydrogel Rx 3 oz
- Primary DI
- 00735549200757
- Version / Model
- 1100075
- Company Name
- Asclepii Inc.
- Labeler DUNS
- 118862618
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-04
- Public Version
- 1
- Public Version Date
- 2025-12-12
- Public Version Status
- New
- Public Device Record Key
- 066e1136-7e7f-458b-87b1-4c5056f2299b
Device Description
Nanosilver Hydrogel wound dressing. Poseidon wound dressing gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59522 | Wound hydrogel dressing, antimicrobial | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00735549200757 | GS1 |
Customer Contacts
- Phone
- +50622721015
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162017 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 30 Degrees Celsius