FDA.reportPublic FDA data

Bagley

Primary DI
08714729043478
Brand
Bagley
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0063401210
Device description
Helical Stone Retrieval Basket
Published
2016-09-24
Public version status
Update
Distribution status
Not 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
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
08714729043478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729043478087147290434788714729043478

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506004583WATCHMAN FLX™ ProM635WU60200M635WU602002023-09-12
00191506004590WATCHMAN FLX™ ProM635WU60240M635WU602402023-09-12
00191506004606WATCHMAN FLX™ ProM635WU60270M635WU602702023-09-12
00191506004613WATCHMAN FLX™ ProM635WU60310M635WU603102023-09-12
00191506004620WATCHMAN FLX™ ProM635WU60350M635WU603502023-09-12
00191506004637WATCHMAN FLX™ ProM635WU60400M635WU604002023-09-12
08714729195573RotaWire™ and wireClip™ TorquerH802232390010H8022323900102014-09-24
08714729195566RotaWire™ and wireClip™ TorquerH802228240020H8022282400202014-09-24
08714729837527Stingray™H749M3004A02016-09-24
08714729877523EP XT™M0042007720M00420077202016-09-24
08714729877714Dynamic XT™M0042011120M00420111202016-09-24
08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14953170458368DISPOSABLE GRASPING FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.FFL2025-05-14
00810143891300Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFL2025-04-25
00810143891317Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFL2025-04-25
B0325550200HaloSACRED HEART MEDICAL,INC.FFL2024-07-18
03600040955482DormiaColoplast A/SFFL2024-04-05
03600040955543DormiaColoplast A/SFFL2024-04-05
03600040955598DormiaColoplast A/SFFL2024-04-05
03600040955659Dormia N.StoneColoplast A/SFFL2024-04-05
03600040955727Dormia N.StoneColoplast A/SFFL2024-04-05
03600040955758Dormia N.StoneColoplast A/SFFL2024-04-05
06936534320465Single Use Urinary Stone Retrieval BasketZhejiang Chuangxiang Medical Technology Co., LTD.FFL2023-10-24
16936881136815Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881136822Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881139380Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881139397Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881150095Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881150101Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16944932724331Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
04055207023273NARichard Wolf GmbHFFL2023-06-20
06971381251647Single-use Extraction BasketsSCIVITA MEDICAL TECHNOLOGY CO., LTD.FFL2023-05-24
16971381251651Single-use Extraction BasketsSCIVITA MEDICAL TECHNOLOGY CO., LTD.FFL2023-05-24
16971381251668Single-use Extraction BasketsSCIVITA MEDICAL TECHNOLOGY CO., LTD.FFL2023-05-24
16971381251675Single-use Extraction BasketsSCIVITA MEDICAL TECHNOLOGY CO., LTD.FFL2023-05-24
03600040326824Dormia DualPercColoplast A/SFFL2023-03-14
03600040326855Dormia DualPercColoplast A/SFFL2023-03-14
04055207018439NARichard Wolf GmbHFFL2022-08-09
04055207023495NARichard Wolf GmbHFFL2022-08-09
B937DOF1511Domia FrontEPflex Feinwerktechnik GmbH.FFL2021-07-23
B937DOF1581Domia FrontEPflex Feinwerktechnik GmbH.FFL2021-07-23
B937DOF2011Domia FrontEPflex Feinwerktechnik GmbH.FFL2021-07-23