FDA UDI
In Commercial Distribution
🇺🇸 United States
Safe N Simple
DI: 00810040132735
·
Model: SNS7322134
·
SAFE N' SIMPLE LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Safe N Simple
- Primary DI
- 00810040132735
- Version / Model
- SNS7322134
- Catalog Number
- SNS7322134
- Company Name
- SAFE N' SIMPLE LLC
- Labeler DUNS
- 807812412
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-10-20
- Public Version
- 1
- Public Version Date
- 2023-10-30
- Public Version Status
- New
- Public Device Record Key
- a975d377-54b1-47b4-939b-8b41ca679444
Device Description
4 1/4" x 4 1/4" 2-Piece Wafer Standard Wear with Tape Collar Beige 45mm 1 3/4" Flange 7/8" Pre Cut Stoma Opening
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 |
|---|---|---|---|---|
| 48159 | Intestinal ostomy base plate, flat | A non-sterile device designed with a flat surface intended to be applied and adhered to peristomal skin (typically of a normal, well-formed stoma) to facilitate the correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. It is typically self-applied by the patient. 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 | 00810040132728 | GS1 | ||||
| Primary | 00810040132735 | GS1 |
Customer Contacts
- Phone
- 248 214 4877
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 4.25 | Inch | |
| Length | 4.25 | Inch |