FDA UDI
In Commercial Distribution
🇺🇸 United States
Isolation Device Mixed pack
DI: 00860013000394
·
Model: 00860013000394
·
Fistula Solution Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Isolation Device Mixed pack
- Primary DI
- 00860013000394
- Version / Model
- 00860013000394
- Catalog Number
- 00860013000394
- Company Name
- Fistula Solution Corporation
- Labeler DUNS
- 007596766
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-30
- Public Version
- 1
- Public Version Date
- 2023-12-08
- Public Version Status
- New
- Public Device Record Key
- 3d22716c-b979-42d7-b95c-8f3e3682a2f5
Device Description
Convenience kit containing 1 each: • REF 00860013000301 Wound Crown® • REF 00860013000325 Fistula Funnel® • REF 00860013000318 Isolator Strip®
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 47658 | Ostomy convexity insert | A device designed to help improve contact between the flange of a two-piece or multiple-piece ostomy appliance and the peristomal skin of a flush stoma or more typically a recessed stoma (a stoma with an adjacent depression, scar, crease, or other condition) for which additional barrier-to-skin contact is desirable. The device is placed between the ostomy appliance flange and the stomal skin typically to fill gaps between the two by providing convexity (an outward bulge), reducing the likelihood of leakage. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860013000394 | GS1 |