FDA.reportPublic FDA data

Cook

Primary DI
00827002032064
Brand
Cook
Company
COOK INCORPORATED
Model
G03206
Catalog number
JCD8.0-35-11
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002032064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002032064008270020320648270020320640827002032064

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450845223Merit Medical®Merit Medical Systems, Inc.DRE2026-03-24
10884450441784SteadySheath®Merit Medical Systems, Inc.DRE2026-03-21
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
10884450441760Evolution® Shortie RLMerit Medical Systems, Inc.DRE2026-03-05
20884450707795Prelude®Merit Medical Systems, Inc.DRE2026-02-14
08033178019545PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019552PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019576PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019583PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
08033178019590PROTEK DILATESORIN GROUP ITALIA SRLDRE2026-01-16
20884450706798Prelude®Merit Medical Systems, Inc.DRE2026-01-16
20884450708945Prelude®Merit Medical Systems, Inc.DRE2026-01-16
10884450847333Merit MAK™Merit Medical Systems, Inc.DRE2025-12-05
10884521811188RitusMozarc Medical US LLCDRE2025-11-27
10884450587185Merit PAK™Merit Medical Systems, Inc.DRE2025-09-05
20884450707177Prelude ACT™Merit Medical Systems, Inc.DRE2025-09-04
20884450708976Prelude®Merit Medical Systems, Inc.DRE2025-08-26
10884450846787Merit MAK Gold™Merit Medical Systems, Inc.DRE2025-08-15
20884450614628Prelude®Merit Medical Systems, Inc.DRE2025-08-14
00763000925116FlexCath Cross™ Transseptal SolutionMEDTRONIC, INC.DRE2025-08-10
00763000925130FlexCath Cross™ Transseptal SolutionMEDTRONIC, INC.DRE2025-08-10
10884450847265Merit MAK Gold™Merit Medical Systems, Inc.DRE2025-08-05
20884450076730Prelude® PROMerit Medical Systems, Inc.DRE2025-07-24
10884450847340Merit S-MAK™Merit Medical Systems, Inc.DRE2025-07-16