FDA.reportPublic FDA data

Gemini

Primary DI
08714729069751
Brand
Gemini
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0063302150
Device description
Paired Wire Helical Stone Retrieval Basket
Published
2016-09-24
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

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
08714729069751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729069751087147290697518714729069751

GMDN Terms#

Term, Definition table
TermDefinition
Urinary stone retrieval basket, single-useA manual endotherapy instrument designed to be inserted through the working channel of an endoscope to trap, retrieve, and/or manipulate urinary stones for the treatment of conditions such as nephrolithiasis and urolithiasis (i.e., presence of calculi in the kidneys or urinary tract). It typically consists of a flexible sheath with a braided self-expanding basket [typically made of nickel-titanium alloy (Nitinol)] at the distal end. A handle located at the proximal end of the instrument is designed to open, close, and rotate the basket. The device is used with a nephroscope or ureteroscope during urological and related procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Regulatory Flags#

DUNS number
021717889
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506063191OPAL HDx™M004OPAL14010M004OPAL140102026-10-28
08714729840442SYNERGY™H7493926108220H74939261082202016-01-14
08714729840459SYNERGY™H7493926108250H74939261082502016-01-14
08714729840466SYNERGY™H7493926108270H74939261082702016-01-14
08714729840473SYNERGY™H7493926108300H74939261083002016-01-14
08714729840480SYNERGY™H7493926108350H74939261083502016-01-14
08714729840497SYNERGY™H7493926108400H74939261084002016-01-14
08714729840503SYNERGY™H7493926112220H74939261122202016-01-14
08714729840510SYNERGY™H7493926112250H74939261122502016-01-14
08714729840527SYNERGY™H7493926112270H74939261122702016-01-14
08714729840534SYNERGY™H7493926112300H74939261123002016-01-14
08714729840541SYNERGY™H7493926112350H74939261123502016-01-14
08714729840558SYNERGY™H7493926112400H74939261124002016-01-14
08714729840565SYNERGY™H7493926116220H74939261162202016-01-14
08714729840572SYNERGY™H7493926116250H74939261162502016-01-14
08714729840589SYNERGY™H7493926116270H74939261162702016-01-14
08714729840596SYNERGY™H7493926116300H74939261163002016-01-14
08714729840602SYNERGY™H7493926116350H74939261163502016-01-14
08714729840619SYNERGY™H7493926116400H74939261164002016-01-14
08714729840626SYNERGY™H7493926120220H74939261202202016-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874546452FlexStone BasketEndoTheia, Inc.FFL2026-10-28
B0325537200HaloSACRED HEART MEDICAL,INC.FFL2026-07-21
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