FDA.report

Cook

Primary DI
00827002145153
Brand
Cook
Company
COOK INCORPORATED
Model
G14515
Catalog number
028003
Device description
Ureteroscopy Occlusion 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

Related Records

Contact Domains

Product Codes

CodeName
EZNDILATOR, CATHETER, URETERAL

Product Code Classifications

CodeDeviceSpecialtyClass
EZNDilator, Catheter, UreteralGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002145153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002145153008270021451538270021451530827002145153

GMDN Terms

TermDefinition
Ureteropelvic balloon catheterA flexible tubular device with an inflatable balloon at the distal end that is placed via the ureter up to the ureteropelvic junction (UPJ) to primarily provide temporary occlusion of the UPJ to prevent stone fragments from lodging in the ureter during a lithotripsy procedure. It may also be used for the injection of a contrast medium for fluoroscopic visualization of UPJ structures, and some types may facilitate the introduction of a compatible endoscope. 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
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
true
No natural rubber latex
false
Sterilization required before use
false

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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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