FDA UDI
In Commercial Distribution
🇺🇸 United States
Advanced Shield Max Silver Barrier, .5oz spray
DI: 00858071004089
·
Model: 6051205
·
Kericure Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Advanced Shield Max Silver Barrier, .5oz spray
- Primary DI
- 00858071004089
- Version / Model
- 6051205
- Catalog Number
- 6510-01-727-1987
- Company Name
- Kericure Inc.
- Labeler DUNS
- 966638681
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-26
- Public Version
- 1
- Public Version Date
- 2025-09-03
- Public Version Status
- New
- Public Device Record Key
- 26e7d3f6-c607-4f03-8887-ff9850882540
Device Description
Topical burn and wound dressing, antimicrobial barrier with silver, 0.5oz spray
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | General, Plastic Surgery | 878.4022 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63108 | Skin semi-occlusive dressing, antimicrobial | A substance (e.g., gel, cream, ointment) intended to be topically applied to injured/diseased skin to expedite skin healing and re-epithelialization primarily through semi-occlusive properties which reduce moisture transmission from the wound to the environment by means of a physical barrier; it also includes an antimicrobial agent(s). It is intended for home/healthcare facility use to treat open skin wounds (e.g., abrasions, lacerations, burns, surgical wounds, ulcers) and/or conditions (e.g., eczema, psoriasis, scars). 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 | 00858071004089 | GS1 |