FDA UDI
In Commercial Distribution
🇺🇸 United States
URGOCLEAN AG PAD
DI: 03546890046461
·
Model: 604060
·
LABORATOIRES URGO
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- URGOCLEAN AG PAD
- Primary DI
- 03546890046461
- Version / Model
- 604060
- Company Name
- LABORATOIRES URGO
- Labeler DUNS
- 397310355
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-14
- Public Version
- 1
- Public Version Date
- 2026-04-22
- Public Version Status
- New
- Public Device Record Key
- 09824b28-c40f-467b-a918-81f884f2a0a5
Device Description
Absorbent dressing consisting of a pad of polyacrylate polyabsorbent fibres coated with TLC Ag matrix Technology composed of liquid paraffin, sodium carboxymethylcellulose (CMC) and silver sulfate and polymers.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47474 | Exudate-absorbent dressing, hydrophilic-gel, antimicrobial | A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03546890042753 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 03546890046461 | GS1 |
Customer Contacts
- Phone
- 855-888-8273
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep away from sunlight, keep dry
- Type
- Storage Environment Temperature
- Temperature Range
- – 77 Degrees Fahrenheit