FDA UDI
In Commercial Distribution
🇺🇸 United States
Totalis™ Rigid Endo Kit
DI: 00801741097591
·
Model: REK32N
·
C. R. Bard, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Totalis™ Rigid Endo Kit
- Primary DI
- 00801741097591
- Version / Model
- REK32N
- Catalog Number
- REK32N
- Company Name
- C. R. Bard, Inc.
- Labeler DUNS
- 016898496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-05-14
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 2d457306-ad7f-49bf-8d92-73378d80a457
Device Description
Totalis™ Rigid Endo Kit with InLay® VersaFit™ Ureteral Stent, EcoFlex™ Stone Basket and NiCore® Nitinol Guidewire
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| FAD | STENT, URETERAL | Gastroenterology, Urology | 876.4620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61177 | Ureteral patency kit | A collection of devices intended to assist treatment of a blocked ureter and to help maintain ureteral patency through natural orifice or percutaneous access. It includes a polymeric ureteral stent, a device(s) intended to trap, retrieve, and/or manipulate urinary stones (e.g., urinary stone retrieval basket), and typically devices associated with access/stent-implantation (e.g., guidewire). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741097598 | GS1 | CA | 5 | In Commercial Distribution | |
| Primary | 00801741097591 | GS1 |
Customer Contacts
- Phone
- +1(800)526-4455
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 6 | French |