FDA UDI
In Commercial Distribution
🇺🇸 United States
NURO™
DI: 00643169654631
·
Model: 3533K
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NURO™
- Primary DI
- 00643169654631
- Version / Model
- 3533K
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 796986144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- da699672-df5e-4e29-90ed-16694391ccf0
Device Description
ACCY 3533K THERAPY SESSION KIT
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAM | STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION | Gastroenterology, Urology | 876.5310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47028 | Tibial nerve percutaneous incontinence-control electrical stimulation system | An assembly of battery-powered devices designed to treat urinary and/or faecal incontinence with electrical stimuli applied to the sacral nerve via percutaneous tibial nerve stimulation (PTNS). It consists of a pair of electrodes, a needle electrode placed into a leg near the ankle and a surface electrode placed on the same leg, and a pulse generator. It produces an adjustable electrical pulse that travels to the sacral nerve plexus via the tibial nerve. It is operated by healthcare personnel who typically apply a predetermined series of treatment sessions to the patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169654631 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132561 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight