FDA.report

Cook

Primary DI
00827002175495
Brand
Cook
Company
COOK INCORPORATED
Model
G17549
Catalog number
STPV-070050
Device description
Stent Positioner
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
KOASURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002175495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002175495008270021754958270021754950827002175495

GMDN Terms

TermDefinition
Ureteral stent-placement setA collection of devices used to facilitate the implantation of a ureteral stent, via the natural orifice or percutaneously through a tortuous ureter, in order to maintain ureteral patency. The devices are typically made of high-grade stainless steel and/or a polymer [e.g., polyvinyl chloride (PVC)] and typically include a guidewire, a dilator, a positioner, an inserter, a placement catheter, an introduction sheath, and a release sleeve. Some of the devices may be radiopaque, and may have Luer connectors at the proximal end to allow for the injection of a contrast medium. 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

Other Devices From This Company

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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

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