FDA.reportPublic FDA data

ROCASTONE Extractor - 1.9Fr - Tipless Basket: 16mm

Primary DI
03700512962762
Brand
ROCASTONE Extractor - 1.9Fr - Tipless Basket: 16mm
Company
Promepla
Model
ROSZ1900ST
Catalog number
ROSZ1900ST
Published
2016-10-03
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#

Product Codes#

Code, Name table
CodeName
FFLDislodger, Stone, Basket, Ureteral, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFLDislodger, Stone, Basket, Ureteral, MetalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700512972761PackageGS11In Commercial Distribution
03700512982760PackageGS14In Commercial Distribution
03700512962762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700512972761037005129727613700512972761
03700512982760037005129827603700512982760
03700512962762037005129627623700512962762

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral catheterA flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+37797984232customer@rocamed.eu

Regulatory Flags#

DUNS number
401020409
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700512905059Irrigation TubeOSG03399E5ST35Y9001972024-10-24
03700512905073Irrigation TubeOSG03499ST35C8237522024-10-24
03700512905196Irrigation TubeODG05599E5ST35Y15000702024-10-24
03700512925064Irrigation TubeOSG03399E5ST35Y9001972024-10-24
03700512925071Irrigation TubeOSG03499ST35C8237522024-10-24
03700512915263Irrigation TubeODG05599E5ST35Y15000702024-10-24
03700512901969Y-CLIC ADAPTER09-0197ROMYCLICST2282018-08-20
03700512963592BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cmROUS1235STROUS1235ST2016-10-03
03700512963608BI-FLEX ACCESS SHEATH - 10 inner / 12 outer - Length 45cmROUS1045STROUS1045ST2016-10-03
03700512963615BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cmROUS1245STROUS1245ST2016-10-03
03700512965589RocaFlex Access Sheath & Dilation Catheter 10/12x35cmAS101235AS1012352016-09-14
03700512965596RocaFlex Access Sheath & Dilation Catheter 12/14x35cmAS101245AS1012452016-09-14
03700512965602RocaFlex Access Sheath & Dilation Catheter 10/12x45cmAS121435AS1214352016-09-14
03700512965619RocaFlex Access Sheath & Dilation Catheter 12/14x45cmAS121445AS1214452016-09-14
03700512966197Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cm09-0015ROUS1035ST2017-11-09
03700512966203Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cm09-0016ROUS1235ST2017-11-09
03700512966210Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm09-0017ROUS1045ST2017-11-09
03700512966227Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cm09-0018ROUS1245ST2017-11-09
03700512967453LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.22cm, without wire09-0124ROJS9522ST2282018-08-20
03700512967460LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.24cm, without wire09-0125ROJS9524ST2282018-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970462547334HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06970462547341HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06970462547358HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06970462547365HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06970462547372HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06970462547389HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06970462547396HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06970462547402HueRex™ Disposable Stone Retrieval BasketShenzhen HugeMed Medical Technical Development Co., Ltd.FFL2026-07-11
06976358502845SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502852SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502869SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502876SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502883SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502890SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502906SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502913SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502920SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502937SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502944SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502951SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502968SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502975SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502982SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358502999SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503002SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503019SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503026SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503033SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503040SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14
06976358503057SEPLOUSEPLOU (ZHUHAI) CO.,LTD.FFL2026-05-14