FDA.reportPublic FDA data

Flexor

Primary DI
00827002461673
Brand
Flexor
Company
COOK INCORPORATED
Model
G46167
Catalog number
FUS-095045
Device description
Flexor, Ureteral Access Sheath with AQ, Hydrophilic Coating
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEDendoscopic access overtube, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002461673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002461673008270024616738270024616730827002461673

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, single-useA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. 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
042823948
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
16925816667210ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
16925816667227ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
16925816667234ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
16970462547454Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547461Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547478Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547485Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547492Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547508Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547515Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547522Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547539Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547546Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547553Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547560Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547577Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547584Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547591Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547607Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16970462547614Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
16925816657518ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657525ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657532ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657549ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657556ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657563ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657570ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657587ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657594ClearPetraWell Lead Medical Co.,LtdFED2026-01-26
16925816657600ClearPetraWell Lead Medical Co.,LtdFED2026-01-26