FDA UDI
In Commercial Distribution
🇺🇸 United States
ESENTA
DI: 00768455209484
·
Model: 423827
·
CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- ESENTA
- Primary DI
- 00768455209484
- Version / Model
- 423827
- Company Name
- CONVATEC, PURCHASING DEPARTMENT
- Labeler DUNS
- 809784593
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2024-08-26
- Public Version
- 2
- Public Version Date
- 2025-03-31
- Public Version Status
- Update
- Public Device Record Key
- ed53ed26-47c7-4115-bf06-382bd2ecb913
Device Description
ESENTA THIN XL SEMI CIRCLE (1X20PK) EUR
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 |
|---|---|---|---|---|
| EXE | Protector, ostomy | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31073 | Intestinal stoma shield/support belt, single-use | A non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. Also known as a stoma protector it is usually attached by the patient to the base plate/wafer that retains the stomal bag, or might be placed directly over the stomal opening when the bag is removed; it may in addition include an attachable ostomy bag protector. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10768455209481 | GS1 | 44 | In Commercial Distribution | ||
| Primary | 00768455209484 | GS1 | ||||
| Unit of Use | 00768455209637 | GS1 |
Customer Contacts
- Phone
- +18004228811
- [email protected]