FDA.report

Cook

Primary DI
00827002537460
Brand
Cook
Company
COOK INCORPORATED
Model
G53746
Catalog number
PU5.0-35-6-W-NS-0-IG
Device description
Irrigation Catheter
Published
2020-10-02
Public version status
New
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
GBXCATHETER, IRRIGATION

Product Code Classifications

CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002537460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002537460008270025374608270025374600827002537460

GMDN Terms

TermDefinition
Biliary/vascular irrigation catheterA sterile, flexible, single-lumen tube intended to access the biliary system during open surgery to introduce fluids (e.g., saline) to irrigate the lumen following a procedure to remove debris (e.g., biliary stone removal); it might additionally be intended to access the peripheral vascular system to introduce fluids (e.g., heparinized solution) to remove debris (e.g., thrombectomy). The device is not intended for percutaneous or endoscopic access, and is not intended for drainage/suction or wound irrigation. 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
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

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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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