FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SUR-FIT NATURA
DI: 00768455116010
·
Model: 416930
·
CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- SUR-FIT NATURA
- Primary DI
- 00768455116010
- Version / Model
- 416930
- Company Name
- CONVATEC, PURCHASING DEPARTMENT
- Labeler DUNS
- 809784593
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2019-03-22
- Public Version
- 6
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- 8c87cbe8-0e01-4f2b-af6f-b5fda8a9a2ec
- Distribution End Date
- 2023-02-26
Device Description
Post Op Kit Sterile: Natura® Two-Piece, Drainable, 4" (100Mm), Transparent, Standard, With Invisiclose® Tail Closure, With Stomahexive® Cut-To-Fit Skin Barrier
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EZP | Rod, Colostomy | Gastroenterology, Urology | 876.4270 | 2 |
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 | 10768455116017 | GS1 | Case | 3 | Not in Commercial Distribution | 2023-02-26 |
| Primary | 00768455116010 | GS1 | ||||
| Unit of Use | 00768455188895 | GS1 |
Customer Contacts
- Phone
- +18004228811
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K811240 | 000 |