FDA.reportPublic FDA data

Cook

Primary DI
00827002103252
Brand
Cook
Company
COOK INCORPORATED
Model
G10325
Catalog number
MCDB-3.0-CE-60
Device description
Mini Compression Dual Balloon Catheter with Silicone Balloons
Published
2020-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002103252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002103252008270021032528270021032520827002103252

GMDN Terms#

Term, Definition table
TermDefinition
Neural-tissue balloon catheterA sterile, flexible tube with a balloon at the distal tip used for the compression or dilation of neural tissue under direct endoscopic or fluoroscopic vision. It is inserted percutaneously over a metal stylet and typically has a small (mini) diameter with an elongated or a double (figure of 8) balloon; it is made of plastic/silicone materials and may be supplied with the stylet. It is typically used to treat trigeminal neuralgia (controlled balloon compression of the trigeminal ganglion causes selected injury to the insulation on nerve fibres which relieves pain). 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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776404000MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404017MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404024MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404031MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404048MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404055MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404062MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404079MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776400262MillenniumAvalign Technologies, Inc.HAO2026-07-21
00190776400545MillenniumAvalign Technologies, Inc.HAO2026-07-19
00190776402105MillenniumAvalign Technologies, Inc.HAO2026-07-19
00190776400286MillenniumAvalign Technologies, Inc.HAO2026-07-17
04058749078794NAFehling Instruments GmbH & Co. KGHAO2026-07-17
00190776400231MillenniumAvalign Technologies, Inc.HAO2026-07-16
00190776395445MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395735MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395742MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395759MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395391MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395407MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395414MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395421MillenniumAvalign Technologies, Inc.HAO2026-07-13
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04946329056457CEA Scissors 180 mm, Sideward Cvd.MIZUHO CORPORATIONHAO2026-05-29
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04946329056471CEA Thin Needle Holder 170 mmMIZUHO CORPORATIONHAO2026-05-29
04946329056488CEA Micro Forceps 180 mm, Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329056495CEA Micro Forceps 180 mm, L Str.MIZUHO CORPORATIONHAO2026-05-29
04946329056501CEA Micro Forceps 150 mm, S Str.MIZUHO CORPORATIONHAO2026-05-29
04946329058802Yasargil micro raspatory, curved, 18.5 cmMIZUHO CORPORATIONHAO2026-05-29