FDA UDI
In Commercial Distribution
🇺🇸 United States
Simpurity
DI: 10810040135979
·
Model: SNS52044
·
SAFE N' SIMPLE LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
64
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Basic Information
- Brand Name
- Simpurity
- Primary DI
- 10810040135979
- Version / Model
- SNS52044
- Catalog Number
- SNS52044
- Company Name
- SAFE N' SIMPLE LLC
- Labeler DUNS
- 807812412
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 64
- Record Status
- Published
- Publish Date
- 2025-06-17
- Public Version
- 1
- Public Version Date
- 2025-06-25
- Public Version Status
- New
- Public Device Record Key
- 8a3d33c9-8275-4bc9-884f-4b01d2339ae7
Device Description
Simpurity Wound Contact Layer 4" x 4"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62069 | Skin semi-occlusive dressing, non-antimicrobial | A substance (e.g., gel, ointment) intended to be topically applied to injured/diseased skin to expedite healing and re-epithelialization primarily through semi-occlusive properties which reduce moisture transmission from the skin to the environment by means of a physical barrier; it may also prevent abnormal scar formation and does not include an antimicrobial agent(s). It is intended for home/healthcare facility use to treat open skin wounds and/or conditions such as lacerations, burns, surgical wounds, radiation dermatitis, and inflammation. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810040135965 | GS1 | ||||
| Primary | 10810040135979 | GS1 |