FDA UDI
In Commercial Distribution
🇺🇸 United States
Simpurity
DI: 00850004779064
·
Model: SNS58859
·
SAFE N' SIMPLE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Simpurity
- Primary DI
- 00850004779064
- Version / Model
- SNS58859
- Catalog Number
- SNS58859
- Company Name
- SAFE N' SIMPLE LLC
- Labeler DUNS
- 807812412
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-30
- Public Version
- 2
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 92be9556-39cf-4896-8c7c-f262b9238646
Device Description
Xeroform 5 x 9 inch Petrolatum Impregnated Gauze (Each)
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 |
|---|---|---|---|---|
| 48132 | Petrolatum woven gauze pad | A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it is impregnated with petrolatum to increase its nonadherent properties. The device is typically used to clean, cover, or pack wounds, abrasions or burns and absorb their exudates, or to absorb body-surface exudates; it is not however a dedicated burn dressing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850004779064 | GS1 |
Customer Contacts
- Phone
- 2482144877
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 9 | Inch | |
| Height | 5 | Inch |