FDA.reportPublic FDA data

Single Use Retrieval Nitinol Basket V

Primary DI
14953170395328
Brand
Single Use Retrieval Nitinol Basket V
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
FG-V451P
Published
2018-03-14
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
LQRDISLODGER, STONE, BILIARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQRDislodger, Stone, BiliaryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170811000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170811000Single Use Retrieval Nitinol Basket VOlympus Medical Systems Corp.2017-11-27LQR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170395328PackageGS11In Commercial Distribution
04953170395321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317039532814953170395328
04953170395321049531703953214953170395321

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
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
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 DIBrandModelCatalogPublished
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503511414Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511421Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511438Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511513Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511520Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511537Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511544Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511551Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511568Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511575Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511582Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511599Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511605Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511612Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511629Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511711eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511728eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511735eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511742eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511759eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511766eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511773eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511780eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511797eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511803eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511810eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511827eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511834eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511841eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28
06932503511858eyeMAX(TM) Extraction BasketMicro-Tech (Nanjing) Co., Ltd.LQR2025-04-28