LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.28cm, without wire
- Primary DI
- 03700512967569
- Brand
- LumaFlex Double J stent, 2 open tips, Ch/Fr7/L.28cm, without wire
- Company
- Promepla
- Model
- 09-0135
- Catalog number
- ROJS9728ST228
- Published
- 2018-08-20
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
rocamed.euProduct Codes#
| Code | Name |
|---|---|
| FAD | Stent, Ureteral |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FAD | Stent, Ureteral | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K173734 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 03700512977568 | Package | GS1 | 1 | In Commercial Distribution |
| 03700512987567 | Package | GS1 | 6 | In Commercial Distribution |
| 03700512967569 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 03700512977568 | 03700512977568 | 3700512977568 |
| 03700512987567 | 03700512987567 | 3700512987567 |
| 03700512967569 | 03700512967569 | 3700512967569 |
GMDN Terms#
| Term | Definition |
|---|---|
| Polymeric ureteral stent | A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation. |
Contacts#
| Phone | |
|---|---|
| +37797984232 | customer@rocamed.eu |
Regulatory Flags#
- DUNS number
- 401020409
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 03700512905059 | Irrigation Tube | OSG03399E5ST35 | Y900197 | 2024-10-24 |
| 03700512905073 | Irrigation Tube | OSG03499ST35 | C823752 | 2024-10-24 |
| 03700512905196 | Irrigation Tube | ODG05599E5ST35 | Y1500070 | 2024-10-24 |
| 03700512925064 | Irrigation Tube | OSG03399E5ST35 | Y900197 | 2024-10-24 |
| 03700512925071 | Irrigation Tube | OSG03499ST35 | C823752 | 2024-10-24 |
| 03700512915263 | Irrigation Tube | ODG05599E5ST35 | Y1500070 | 2024-10-24 |
| 03700512901969 | Y-CLIC ADAPTER | 09-0197 | ROMYCLICST228 | 2018-08-20 |
| 03700512963592 | BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cm | ROUS1235ST | ROUS1235ST | 2016-10-03 |
| 03700512963608 | BI-FLEX ACCESS SHEATH - 10 inner / 12 outer - Length 45cm | ROUS1045ST | ROUS1045ST | 2016-10-03 |
| 03700512963615 | BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cm | ROUS1245ST | ROUS1245ST | 2016-10-03 |
| 03700512965589 | RocaFlex Access Sheath & Dilation Catheter 10/12x35cm | AS101235 | AS101235 | 2016-09-14 |
| 03700512965596 | RocaFlex Access Sheath & Dilation Catheter 12/14x35cm | AS101245 | AS101245 | 2016-09-14 |
| 03700512965602 | RocaFlex Access Sheath & Dilation Catheter 10/12x45cm | AS121435 | AS121435 | 2016-09-14 |
| 03700512965619 | RocaFlex Access Sheath & Dilation Catheter 12/14x45cm | AS121445 | AS121445 | 2016-09-14 |
| 03700512966197 | Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cm | 09-0015 | ROUS1035ST | 2017-11-09 |
| 03700512966203 | Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm | 09-0016 | ROUS1235ST | 2017-11-09 |
| 03700512966210 | Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm | 09-0017 | ROUS1045ST | 2017-11-09 |
| 03700512966227 | Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cm | 09-0018 | ROUS1245ST | 2017-11-09 |
| 03700512967453 | LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.22cm, without wire | 09-0124 | ROJS9522ST228 | 2018-08-20 |
| 03700512967460 | LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.24cm, without wire | 09-0125 | ROJS9524ST228 | 2018-08-20 |
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