FDA.reportPublic FDA data

Coda

Primary DI
00827002360426
Brand
Coda
Company
COOK INCORPORATED
Model
G36042
Catalog number
CODA-10.0-35-100-32
Device description
Coda, Balloon Catheter
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
DQYCATHETER, PERCUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002360426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002360426008270023604268270023604260827002360426

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. 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
04544050121057CELLO II Balloon Guide Catheter, 8F 90cmFUJI SYSTEMS CORPORATIONDQY2026-05-25
00763000821296Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821302Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821319Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821326Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821333Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821340Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821357Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821364Attain Select™ II + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821371Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821388Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821395Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821425Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821432Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821449Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821456Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821463Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821470Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821487Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
00763000821500Attain Command™ + SureValve™MEDTRONIC, INC.DQY2026-05-22
30841156103983SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156103993SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104006SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104013SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104020SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104037SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104044SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
30841156104058SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20801902195429ARROWTELEFLEX INCORPORATEDDQY2026-03-17
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05