Spes Medica Pudendal Electrode
- Primary DI
- 08054655012897
- Brand
- Spes Medica Pudendal Electrode
- Company
- SPES MEDICA SRL
- Model
- PUD0001
- Published
- 2020-03-11
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | Gastroenterology, Urology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 18054655012894 | Primary | GS1 | 0 | |
| 08054655012897 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 18054655012894 | 18054655012894 | |
| 08054655012897 | 08054655012897 | 8054655012897 |
GMDN Terms#
| Term | Definition |
|---|---|
| Urodynamic measurement system | An assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters. A diagnostic urodynamic evaluation consists of uroflowmetry (measurement of urinary flow rate), urethral pressure profilometry (measurement of urethral pressure), gas or water cystometry (measurement of bladder capacity and response), and electromyogram (EMG) recording (the measurement of sphincter and other muscle activity). Long-term recording may also be analysed. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 514029771
- Device count
- 10
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08054655020793 | Connection cable | SBM1AE001 | 2024-05-13 | |
| 08054655021707 | Connection cable | SBM1AE002 | 2024-05-13 | |
| 08054655021714 | Connection cable | SBM1AE003 | 2024-05-13 | |
| 08054655030037 | Connection cable | SBM1AE004 | 2024-05-13 | |
| 08054655023664 | AC Cream - Conductive Paste | ACCREAM250V-3 | 2021-12-22 | |
| 08054655031843 | SafePrep | NPREP010E-1 | 2021-08-05 | |
| 08054655031034 | Disposable Adhesive Surface Electrodes | TEON2F5090 | 2021-03-23 | |
| 08054655031041 | Disposable Adhesive Surface Electrodes | TEON2F100150F | 2021-03-23 | |
| 08054655030723 | IOM Stimulator Probes | SI1B0185S2526D | 2021-02-04 | |
| 08054655010879 | Spes Medica Subdermal Needle Electrodes | MN2013D10S | 2020-08-11 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 18054655025986 | Urethral Catheter Electrode | SPES MEDICA SPA | FAP | 2025-02-24 |
| 18054655026006 | Urethral Catheter Electrode | SPES MEDICA SPA | FAP | 2025-02-24 |
| 18054655030386 | Urethral Catheter Electrode | SPES MEDICA SPA | FAP | 2025-02-24 |
| 18054655025979 | Urethral Catheter Electrode | SPES MEDICA SPA | FAP | 2021-05-24 |
| 18054655026013 | Urethral Catheter Electrode | SPES MEDICA SPA | FAP | 2021-05-24 |
| 18054655012894 | Spes Medica Pudendal Electrode | SPES MEDICA SPA | FAP | 2020-03-11 |
| 00827002156036 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002157392 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002158580 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002158733 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002158931 | Madduri | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002158993 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002161696 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002167056 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002167803 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002168909 | Dewan | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002169876 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002170438 | Joseph | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002171749 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002172302 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002172524 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002172586 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002173187 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002152847 | Silber | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002154292 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002154346 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002154353 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 00827002155404 | Cook | COOK INCORPORATED | FAP | 2016-09-24 |
| 04026704072514 | RUSCH | TELEFLEX INCORPORATED | FAP | 2016-09-16 |