FDA.report

Cook

Primary DI
00827002142145
Brand
Cook
Company
COOK INCORPORATED
Model
G14214
Catalog number
073700
Device description
Fascial Dilator 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

Related Records

Contact Domains

Product Codes

CodeName
KOEDILATOR, URETHRAL

Product Code Classifications

CodeDeviceSpecialtyClass
KOEDilator, UrethralGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002142145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002142145008270021421458270021421450827002142145

GMDN Terms

TermDefinition
Fascial tissue dilator, single-useA surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose, inflatable balloon or screw-tip at its distal end, that is available in a variety of sizes and typically made of metal or plastic. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods

Method

Contacts

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

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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

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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