FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SUR-FIT NATURA
DI: 00768455133277
·
Model: 421047
·
CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- SUR-FIT NATURA
- Primary DI
- 00768455133277
- Version / Model
- 421047
- Company Name
- CONVATEC, PURCHASING DEPARTMENT
- Labeler DUNS
- 809784593
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2018-11-09
- Public Version
- 9
- Public Version Date
- 2023-05-31
- Public Version Status
- Update
- Public Device Record Key
- 2890fe5a-41b8-49a8-a0ba-230060b4f783
- Distribution End Date
- 2023-05-31
Device Description
Post Op Kit: Natura Durahesive Moldable Skin Barrier - Accordion Flange, Drainable, With Invisiclose® Tail Closure 33-45Mm
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
- No
- 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 |
|---|---|---|---|---|
| FON | Bag, Drainage, With Adhesive, Ostomy | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31076 | Multiple-piece intestinal ostomy bag, open-ended | A plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It consists of two or more separate parts including the pouch with a flange and a base plate, both having a flange locking mechanism. The distal end of the pouch can be opened for drainage of the waste and emptied, e.g., several times per day. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10768455133274 | GS1 | Case | 6 | Not in Commercial Distribution | 2023-05-31 |
| Primary | 00768455133277 | GS1 | ||||
| Unit of Use | 00768455133895 | GS1 |
Customer Contacts
- Phone
- +18004228811
- [email protected]