FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Securi-T
DI: 00610075069996
·
Model: 7610258
·
HOLLISTER INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Securi-T
- Primary DI
- 00610075069996
- Version / Model
- 7610258
- Catalog Number
- 7610258
- Company Name
- HOLLISTER INCORPORATED
- Labeler DUNS
- 005527098
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 2
- Public Version Date
- 2025-06-03
- Public Version Status
- Update
- Public Device Record Key
- dcfbedeb-f3dd-4275-bf21-c553fca834ff
- Distribution End Date
- 2025-05-30
Device Description
1-Pc Ostomy System, 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 |
|---|---|---|---|---|
| EXG | BAG, URINE COLLECTING, URETEROSTOMY | Gastroenterology, Urology | 876.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64583 | One-piece urostomy bag, open-ended | A one-piece plastic pouch designed to be attached with adhesive to a patient's skin around a stoma for use as a urine collection device in the management of urinary diversions; it includes a drainage tap to permit the emptying of fluids (open-ended). The entire device is removed when changed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00610075069996 | GS1 | ||||
| Unit of Use | 20610075069990 | GS1 |
Customer Contacts
- Phone
- +1(800)323-4060
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 25 | Millimeter |