FDA.reportPublic FDA data

Cook

Primary DI
00827002216976
Brand
Cook
Company
COOK INCORPORATED
Model
G21697
Catalog number
LDVI-25
Device description
Disposable Varices Injector
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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBKendoscopic injection needle, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBKEndoscopic Injection Needle, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K851952000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K851952000VARICES INJECTORWilson-Cook Medical, Inc.1985-07-26FBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002216976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002216976008270022169768270022169760827002216976

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
079720472
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800035704711CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704728CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704841CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704858CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704865CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704872CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704889CORE-INJECTORINCORE CO., LTDFBK2026-02-06
08800035704896CORE-INJECTORINCORE CO., LTDFBK2026-02-06
06974296705915AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296706004AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296706479AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707131AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707285AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707377AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2026-01-26
06974296707315AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707322AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707339AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
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06974296707353AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06974296707360AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06942127812477AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06942127815362AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671385963AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671385994AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671386144AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
06970671386175AltonAlton (Shanghai) Medical Instruments Co., Ltd.FBK2025-12-29
05420051305209G-FlexG-Flex EuropeFBK2025-06-02
05420051305216G-FlexG-Flex EuropeFBK2025-06-02
05420051305247G-FlexG-Flex EuropeFBK2025-06-02
05420051306008G-FlexG-Flex EuropeFBK2025-06-02