FDA UDI
In Commercial Distribution
🇺🇸 United States
Ritus
DI: 10884521811164
·
Model: 8815544010
·
Mozarc Medical US LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ritus
- Primary DI
- 10884521811164
- Version / Model
- 8815544010
- Company Name
- Mozarc Medical US LLC
- Labeler DUNS
- 118997146
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-20
- Public Version
- 1
- Public Version Date
- 2026-04-28
- Public Version Status
- New
- Public Device Record Key
- 6e04b9d5-e257-4176-88e9-7051c1e4f403
Device Description
Chronic Catheter Accessory,Pull Apart Introducer Set for Inserting Catheters and Pacing Leads,16 Fr/Ch (5.3 mm)
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 |
|---|---|---|---|---|
| FKO | CATHETER, PERITONEAL DIALYSIS, SINGLE USE | Gastroenterology, Urology | 876.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63230 | Vascular catheter introduction set, implantable | A collection of devices which includes an implantable device(s) intended to provide percutaneous, peripheral, arterial access to enable repeated introduction of a catheter (not included) into the vascular system over an extended period (e.g., months) without vascular wound closure. It includes an implantable non-steerable introducer sheath, an inner obturator/occluder, and typically an additional access device(s) [e.g., haemostatic valve, stylet]. The introducer sheath is typically anastomosed to the blood vessel and externalised via a subcutaneous tunnel; the occluder is intended to plug the introducer sheath between uses. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10884521811164 | GS1 |
Customer Contacts
- Phone
- +39053529111
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 16 | French |