FDA UDI
In Commercial Distribution
🇺🇸 United States
New Image
DI: 00610075097593
·
Model: 157105
·
HOLLISTER INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- New Image
- Primary DI
- 00610075097593
- Version / Model
- 157105
- Catalog Number
- 157105
- Company Name
- HOLLISTER INCORPORATED
- Labeler DUNS
- 005527098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2025-10-10
- Public Version
- 1
- Public Version Date
- 2025-10-20
- Public Version Status
- New
- Public Device Record Key
- e7ae69a2-c9ee-44e3-a4d7-654650698ed1
Device Description
2-Piece Ostomy Skin Barrier, CeraPlus, Soft Convex
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EXB | Collector, ostomy | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48158 | Intestinal ostomy base plate, convex | A non-sterile device designed with a convex surface intended to be applied and adhered to peristomal skin to facilitate correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. The convexity of the device is used to improve peristomal skin contact of a flush stoma or more typically a recessed stoma. It is typically self-applied by the patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10610075097590 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00610075097593 | GS1 | ||||
| Unit of Use | 00610075096879 | GS1 |
Customer Contacts
- Phone
- +1(800)323-4060
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 57 | Millimeter | |
| Lumen/Inner Diameter | 29 | Millimeter |