FDA.reportPublic FDA data

Nitinol Stone Extractor, straight basket, 4 wires, 2.5 Fr

Primary DI
03700512986232
Brand
Nitinol Stone Extractor, straight basket, 4 wires, 2.5 Fr
Company
Promepla
Model
09-0019
Catalog number
ROSS2500ST
Published
2017-11-09
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

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
03700512976233PackageGS11In Commercial Distribution
03700512986232PackageGS14In Commercial Distribution
03700512966234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700512976233037005129762333700512976233
03700512986232037005129862323700512986232
03700512966234037005129662343700512966234

GMDN Terms#

Term, Definition table
TermDefinition
Biliary/urinary stone retrieval basket, single-useA flexible, manual instrument designed to trap/retrieve biliary and/or urinary stones (gallbladder and/or renal/ureteric calculi) from the body during an endoscopic procedure [e.g., endoscopic retrograde cholangiopancreatography (ERCP)]; it is not intended to fragment/crush. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire (typically metallic) at its distal end in which the stones are caught. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
401020409
Device count
1
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
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 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
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
06973356553886TriousShenzhen Trious Medical Technology Co., Ltd.FFL2026-05-09
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06973356553961TriousShenzhen Trious Medical Technology Co., Ltd.FFL2026-04-22
00810116023721Dornier MedTech DORNIER MEDTECH AMERICA, INC.FFL2026-04-21
00810116023738Dornier MedTech DORNIER MEDTECH AMERICA, INC.FFL2026-04-21
00810116023745Dornier MedTech DORNIER MEDTECH AMERICA, INC.FFL2026-04-21
04953170458361DISPOSABLE GRASPING FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.FFL2025-05-14