FDA UDI
In Commercial Distribution
🇺🇸 United States
INTERSTIM
DI: 00613994601964
·
Model: 3889-33
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INTERSTIM
- Primary DI
- 00613994601964
- Version / Model
- 3889-33
- 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
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- 8a52bae6-0e85-4207-8490-3b208f8b873a
Device Description
LEAD 3889-33 TINED QUAD SNS US
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 |
|---|---|---|---|---|
| EZW | Stimulator, electrical, implantable, for incontinence | Gastroenterology, Urology | 876.5270 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44045 | Sacral plexus implantable incontinence-control electrical stimulation system electrode | An implantable wire, insulated with non-conductive material except at its electrode(s), intended to be used to treat chronic disorders of the pelvis and lower urinary or intestinal tract, typically related to urinary and/or faecal incontinence. It is implanted on the sacral plexus or in its vicinity (e.g., anal sphincter, bladder wall, pelvic floor) to make an electrical connection between an implantable electrical stimulation system pulse generator and the sacral plexus area. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613994601964 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970004 | 073 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 33.0 | Centimeter |