FDA.reportPublic FDA data

Hatter

Primary DI
00827002152793
Brand
Hatter
Company
COOK INCORPORATED
Model
G15279
Catalog number
050040-S6
Device description
Hatter Flexible Cystoscopy Aspiration Tube
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
KNSUnit, electrosurgical, endoscopic (with or without accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002152793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002152793008270021527938270021527930827002152793

GMDN Terms#

Term, Definition table
TermDefinition
Urethral/ureteral catheter connector, sterileA small, sterile, connecting device intended to create a mechanical union between the proximal end of urethral and/or ureteral catheter and an external device (e.g., irrigation/vacuum unit, syringe, urine drainage bag) to enable infusion, drainage, or other procedures to be performed through the lumen of the catheter; it has no additional functions (e.g., not a two-way valve). It may also be intended to connect a urinary condom catheter (a penis sheath-type catheter) to a urine drainage bag. 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
08809909421709CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-27
08809909421716CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-27
08809909421693CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-24
04545499074423SB Knife Jr2SB-KAWASUMI LABORATORIES, INC.KNS2026-04-06
04545499074430SB Knife Jr2 /Long typeSB-KAWASUMI LABORATORIES, INC.KNS2026-04-06
00827002613515SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002613522SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002597501Tesla BicordCOOK INCORPORATEDKNS2025-07-11
00724995226732Padlock ClipUS EndoscopyKNS2024-10-31
08809922260637ELRA ElectrodeSTARMED CO.,LTDKNS2024-08-28
04055207007822NARichard Wolf GmbHKNS2024-08-19
04055207008393NARichard Wolf GmbHKNS2024-08-19
04055207058985NARichard Wolf GmbHKNS2024-08-19
20653405051555APOLLO3Conmed CorporationKNS2024-07-22
20653405051562APOLLO3Conmed CorporationKNS2024-07-22
03665415002116Electrosurgical Unit MCBLAMIDEY NOURY MEDICALKNS2023-04-21
00851925007885Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.KNS2023-03-08
00884450329665Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450502006Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450502013Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450502020Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450329658Brighton™Merit Medical Systems, Inc.KNS2021-06-15
00884450501993Brighton™Merit Medical Systems, Inc.KNS2021-06-15
00191506008086Axios™BOSTON SCIENTIFIC CORPORATIONKNS2021-05-27
00191506008093Axios™BOSTON SCIENTIFIC CORPORATIONKNS2021-05-27
00816207021577ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021584ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021591ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021607ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021614ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29