FDA UDI
In Commercial Distribution
🇺🇸 United States
ALLEVYN™ Ag+
DI: 05000223501631
·
Model: 66027670
·
SMITH & NEPHEW MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- ALLEVYN™ Ag+
- Primary DI
- 05000223501631
- Version / Model
- 66027670
- Catalog Number
- 66027670
- Company Name
- SMITH & NEPHEW MEDICAL LIMITED
- Labeler DUNS
- 216344051
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-12
- Public Version
- 1
- Public Version Date
- 2025-08-20
- Public Version Status
- New
- Public Device Record Key
- 6a82e6c0-d811-4591-97b1-110f689263d5
Device Description
ALLEVYN Ag+ Sacrum 8.5in x 9.1in
Device Characteristics
- Single Use
- Yes
- 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
- MR Safe
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 47042 | Wound-nonadherent dressing, absorbent, antimicrobial | A wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05000223501815 | GS1 | CAS | 5 | In Commercial Distribution | |
| Package | 05000223501723 | GS1 | CAR | 10 | In Commercial Distribution | |
| Primary | 05000223501631 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223526 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight: -
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry: -
- Type
- Special Storage Condition, Specify
- Special Conditions
- Temperature limit: -