FDA UDI
In Commercial Distribution
🇺🇸 United States
InterStim iCon
DI: 00613994572059
·
Model: 3037
·
MEDTRONIC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- InterStim iCon
- Primary DI
- 00613994572059
- Version / Model
- 3037
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-23
- Public Version
- 5
- Public Version Date
- 2025-12-16
- Public Version Status
- Update
- Public Device Record Key
- 161023d4-997e-4da7-b111-9b8891ae0701
Device Description
PRGMR 3037 INTERSTIM PATIENT SW UPDATE
Device Characteristics
- Single Use
- No
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EZW | Stimulator, electrical, implantable, for incontinence | Gastroenterology, Urology | 876.5270 | 3 |
| QON | Implanted electrical device intended for treatment of fecal incontinence | Gastroenterology, Urology | 876.5270 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61396 | Implantable incontinence-control electrical stimulation system programmer, battery-powered | A portable, battery-powered external device intended to change, noninvasively, one or more of the operating parameters (the programs) of an implanted incontinence-control electrical stimulation system pulse generator. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It will typically also provides historic and/or current information regarding the performance of the implant. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613994572059 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970004 | 062 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 150 Degrees Fahrenheit
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 65 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 95 Percent (%) Relative Humidity