FDA UDI
In Commercial Distribution
🇺🇸 United States
Safe N Simple
DI: 00810040134210
·
Model: SNS7900222
·
SAFE N' SIMPLE LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- Safe N Simple
- Primary DI
- 00810040134210
- Version / Model
- SNS7900222
- Catalog Number
- SNS7900222
- Company Name
- SAFE N' SIMPLE LLC
- Labeler DUNS
- 807812412
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2023-11-01
- Public Version
- 1
- Public Version Date
- 2023-11-09
- Public Version Status
- New
- Public Device Record Key
- 6cb78ef5-8010-43b2-b5c8-857c1f0dcf82
Device Description
2" Skin Barrier Rings, 2mm thickness, 20 pcs/bx - 8 boxes/case
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EZS | Appliance, Colostomy, Disposable | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46207 | Peristomal/periwound dressing | A non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is typically available in a variety of forms including cream, paste in a tube or other applicator, paste in ready formed strips, or powder. 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 | 00810040134203 | GS1 | ||||
| Primary | 00810040134210 | GS1 |
Customer Contacts
- Phone
- 248 214 4877
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2 | Inch |