FDA UDI
In Commercial Distribution
🇺🇸 United States
ESENTA
DI: 00768455197347
·
Model: 423283/4
·
CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- ESENTA
- Primary DI
- 00768455197347
- Version / Model
- 423283/4
- Catalog Number
- 423283/4
- Company Name
- CONVATEC, PURCHASING DEPARTMENT
- Labeler DUNS
- 809784593
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-30
- Public Version
- 3
- Public Version Date
- 2023-07-13
- Public Version Status
- Update
- Public Device Record Key
- c75b4dea-1b2a-433c-8e12-792756601b56
Device Description
Esenta™ Skin Barrier Foam Applicator 1 ml, Sterile (5 per pack)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 58978 | Synthetic-polymer liquid barrier dressing | A liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10768455170064 | GS1 | 4 | In Commercial Distribution | ||
| Package | 00768455170067 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 00768455197347 | GS1 | ||||
| Package | 10768455170057 | GS1 | 20 | In Commercial Distribution | ||
| Package | 00768455170050 | GS1 | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +18004228811
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1.00000 | Milliliter |