FDA UDI
In Commercial Distribution
🇺🇸 United States
Wound GelHA TM
DI: 00358407070011
·
Model: One, 0.33 oz (9.45g) Tube
·
Industria Farmacéutica Andrómaco, S.A. de C.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Wound GelHA TM
- Primary DI
- 00358407070011
- Version / Model
- One, 0.33 oz (9.45g) Tube
- Company Name
- Industria Farmacéutica Andrómaco, S.A. de C.V.
- Labeler DUNS
- 810330282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-13
- Public Version
- 1
- Public Version Date
- 2022-05-23
- Public Version Status
- New
- Public Device Record Key
- f230db6c-f9aa-41ed-80db-92e92b4e9455
Device Description
WoundGelHA TM is indicated for the management of minor burns, abrasions, & cuts and helps relieve dry waxy skinassociated with dry skin conditions.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 58133 | Skin osmotic dressing, non-antimicrobial | A substance (e.g., ointment, cream, spray, impregnated material) intended to be topically applied to the skin (e.g., face, eyelids, extremities) and containing compounds [e.g., hyaluronic acid (HA), plant oil extracts] intended to expedite wound healing and skin re-epithelialization primarily through osmotic properties which absorb and retain water to create a moist environment; it does not include antimicrobial agents. It may be used to treat superficial and/or deep wounds (e.g., abrasions, lacerations, burns, surgical wounds, decubitus sores, ulcers). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00358407070011 | GS1 |