Home GUDID 03700512987536 LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.30cm, without wire
Primary DI 03700512987536
Brand LumaFlex Double J stent, 2 open tips, Ch/Fr6/L.30cm, without wire
Company Promepla
Model 09-0132
Catalog number ROJS9630ST228
Published 2018-08-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FAD Stent, Ureteral
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FAD Stent, Ureteral Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03700512977537 Package GS1 1 In Commercial Distribution 03700512987536 Package GS1 6 In Commercial Distribution 03700512967538 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03700512977537 03700512977537 3700512977537 03700512987536 03700512987536 3700512987536 03700512967538 03700512967538 3700512967538
GMDN Terms# Term, Definition table 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.
Regulatory Flags# DUNS number 401020409 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table 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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