FDA UDI
In Commercial Distribution
🇺🇸 United States
Simpurity
DI: 20810040131893
·
Model: SNS52377
·
SAFE N' SIMPLE LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
480
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Basic Information
- Brand Name
- Simpurity
- Primary DI
- 20810040131893
- Version / Model
- SNS52377
- Catalog Number
- SNS52377
- Company Name
- SAFE N' SIMPLE LLC
- Labeler DUNS
- 807812412
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 480
- 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
- b3b9fe97-c7f8-438e-ba3e-983cb3c216ce
Device Description
7" x 7" Bordered Gauze with Tefla - 9" x 9" Overall Size
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 |
|---|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48134 | Woven gauze pad, non-antimicrobial | 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 does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810040131899 | GS1 | ||||
| Primary | 20810040131893 | GS1 |