FDA UDI
In Commercial Distribution
🇺🇸 United States
Ritus
DI: 10884521811201
·
Model: 8817791001
·
Mozarc Medical US LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Ritus
- Primary DI
- 10884521811201
- Version / Model
- 8817791001
- Company Name
- Mozarc Medical US LLC
- Labeler DUNS
- 118997146
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-21
- Public Version
- 6
- Public Version Date
- 2026-04-17
- Public Version Status
- Update
- Public Device Record Key
- 76279d0c-7e89-4e53-845e-796e7c32beeb
Device Description
Peritoneal Dialysis Accessory Blunt Tunneling Stylet
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| FJS | Catheter, peritoneal, long-term indwelling | Gastroenterology, Urology | 876.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13837 | Peritoneal catheter stylet | A thin wire/rod intended to be inserted within the lumen of a peritoneal catheter (e.g., peritoneal dialysis catheter, peritoneal drainage catheter, peritoneal lavage catheter, abdominal fluid shunt system peritoneal catheter) to stiffen/maintain the shape of the catheter to assist introduction; it may also be intended to assist insertion of a bladder catheter used for drainage of fluid from the peritoneal cavity to the bladder. It is intended to be removed once the catheter is in place. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884521811208 | GS1 | PACK_OR_INNER_PACK | 5 | In Commercial Distribution | |
| Primary | 10884521811201 | GS1 |
Customer Contacts
- Phone
- +39053529111
- [email protected]