FDA.reportPublic FDA data

Cook

Primary DI
00827002142701
Brand
Cook
Company
COOK INCORPORATED
Model
G14270
Catalog number
074012
Device description
Safety Wire Guide Introducer Set
Published
2016-09-24
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
KOEDILATOR, URETHRAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOEDilator, UrethralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002142701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002142701008270021427018270021427010827002142701

GMDN Terms#

Term, Definition table
TermDefinition
Encapsulating-tissue dilation sheathA sterile, hand-held, manual surgical instrument designed for the percutaneous dilation of tissue surrounding a device or object that has been previously placed or found within a patient's body (e.g., cardiac leads, indwelling catheter, foreign object). It is a single-lumen, catheter-like device (a sheath) with a long, slender, tubular body; its narrow distal tip typically includes radiopaque markers to enable fluoroscopic identification of tip location and orientation. It is typically made of stainless steel and is available in various lengths and diameters. It may also be used for the introduction and support of intravascular catheters. 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
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
true
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
00827002613508SureTome SWG61350SUR-SW-352025-12-08
10827002613512SureTome SWG61351SUR-SW-AWG2-35-2602025-12-08
10827002613529SureTome SWG61352SUR-SW-AWG2-35-4502025-12-08
10827002242378BakriG24237J-SOSR-1005002016-09-24
10827002306735BakriG30673J-SOS-1005002016-09-24
00827002607842COOKG60784TESLA-B2535-2602025-07-22
00827002607859COOKG60785TESLA-B2535-4502025-07-22
10827002597508COOKG59750TESLA-B-ACU2025-07-11
10827002496535Cotton-Leung Sof-FlexG49653CLSO-SF-10-52015-11-03
00827002352674HerculesG35267HBDE-W-8-9-102022-12-20
00827002352681HerculesG35268HBDE-W-10-11-122022-12-20
00827002352698HerculesG35269HBDE-W-12-13.5-152022-12-20
00827002352704HerculesG35270HBDE-W-15-16.5-182022-12-20
00827002352711HerculesG35271HBDE-W-18-19-202022-12-20
10827002346014FusionG34601FS-OMNI-ACRO-35-2052016-09-24
10827002346939FusionG34693FS-OMNI-ACRO-35-2602016-09-24
10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
10827002347783D.A.S.H.G34778DASH-ACRO-35-4502016-09-24
10827002347790D.A.S.H.G34779DASH-ACRO-25-4502016-09-24
10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00853095008341Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008358Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008365Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008372Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008389Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008396Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00856877002759QL Disposable Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2025-05-16
00856877002766Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2025-05-16
00856877002773Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2025-05-16
00856877002704Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2024-08-06
06936534328683Single Use Urethral DilatorZhejiang Chuangxiang Medical Technology Co., LTD.KOE2023-10-24
16936881102537Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136389Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136396Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136402Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136419Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136426Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136433Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136440Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136457Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136464Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136471Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136481Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881102513Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
16936881102520Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
16936881136495Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
06936881140716Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
16944932769882Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
00856877002728QL Disposable Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2022-11-07
08718455508270MED pro Medical B.V.MED pro Medical B.V.KOE2022-09-09