FDA.reportPublic FDA data

Cook

Primary DI
00827002009950
Brand
Cook
Company
COOK INCORPORATED
Model
G00995
Catalog number
JCD12.0-38-20
Device description
Dilator
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
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
FGEStents, drains and dilators for the biliary ducts

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002009950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002009950008270020099508270020099500827002009950

GMDN Terms#

Term, Definition table
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#

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
true
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16932503515631Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515648Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515655Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515662Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
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16932503515716Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515723Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515730Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515747Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515754Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515761Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515778Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515785Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515792Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515808Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
10884450441616Evolution® RLMerit Medical Systems, Inc.DRE2026-03-11
10884450441746Evolution® RLMerit Medical Systems, Inc.DRE2026-03-11
10884450441753Evolution® RLMerit Medical Systems, Inc.DRE2026-03-11
10884450441623Evolution® RLMerit Medical Systems, Inc.DRE2026-03-10
10884450441777SteadySheath®Merit Medical Systems, Inc.DRE2026-03-06
10884450441791SteadySheath®Merit Medical Systems, Inc.DRE2026-03-06
10884450441807SteadySheath® ShortieMerit Medical Systems, Inc.DRE2026-03-06