FDA UDI
In Commercial Distribution
🇺🇸 United States
INTERSTIM®
DI: 00613994287731
·
Model: 3023
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INTERSTIM®
- Primary DI
- 00613994287731
- Version / Model
- 3023
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 796986144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-23
- Public Version
- 4
- Public Version Date
- 2020-04-06
- Public Version Status
- Update
- Public Device Record Key
- f3405778-1af1-4d7f-8be0-da60d95750f9
Device Description
Neurostimulator 3023 US InterStim
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| EZW | Stimulator, electrical, implantable, for incontinence | Gastroenterology, Urology | 876.5270 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36175 | Sacral plexus implantable incontinence-control electrical stimulation system | An assembly of battery-powered devices intended to treat urinary and/or faecal incontinence through the application of electrical stimuli to the muscles and/or neural tissue of the pelvic floor/bladder. It consists of an electrode implanted on or in the vicinity of the sacral plexus, a pulse generator with a receiver typically implanted in the abdomen/pelvic region, and an external programmer/transmitter that communicates with the implanted receiver. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613994287731 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970004 | 002 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 125 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 52 Degrees Celsius