FDA UDI
In Commercial Distribution
🇺🇸 United States
SUR-FIT NATURA
DI: 00768455104444
·
Model: 404027
·
CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- SUR-FIT NATURA
- Primary DI
- 00768455104444
- Version / Model
- 404027
- Company Name
- CONVATEC, PURCHASING DEPARTMENT
- Labeler DUNS
- 809784593
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2019-04-12
- Public Version
- 3
- Public Version Date
- 2022-10-07
- Public Version Status
- Update
- Public Device Record Key
- 32a70674-1ea4-488a-99f1-549b5793680b
Device Description
SUR-FIT Natura® Drainable Pouch, 12" Opaque W/2-Sided Comfort Panel, 1 3/4" (45Mm.)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| EZQ | Pouch, Colostomy | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31069 | Multiple-piece urostomy bag, open-ended | A plastic pouch composed of two or more parts [e.g., a barrier (wafer) and a pouch; both having flange/locking mechanisms] designed to attach to a patient's skin around a stoma for use as a urinary collection device in the management of urinary diversions. It has a non-return valve to prevent urine from pooling at the base of the stoma. It also has a drainage tap to permit the emptying of fluids. The barrier (wafer) remains attached around the stoma when the bag is removed/changed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10768455104441 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00768455104444 | GS1 | ||||
| Unit of Use | 00768455184903 | GS1 |
Customer Contacts
- Phone
- +18004228811
- [email protected]