FDA.reportPublic FDA data

Universa

Primary DI
00827002558243
Brand
Universa
Company
COOK INCORPORATED
Model
G55824
Catalog number
UMCP-14-30
Device description
Universa Malecot Drainage Catheter Suprapubic Set
Published
2016-12-09
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
LJECATHETER, NEPHROSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJECatheter, NephrostomyUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002558243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002558243008270025582438270025582430827002558243

GMDN Terms#

Term, Definition table
TermDefinition
Nephrostomy catheterA sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. 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
00860000917506RetroPercRETROPERC INC.LJE2025-01-09
05701780270878KolibriColoplast A/SLJE2023-01-20
05701780270908KolibriColoplast A/SLJE2023-01-20
05701780270939KolibriColoplast A/SLJE2023-01-20
05701780270977KolibriColoplast A/SLJE2023-01-20
05701780271042KolibriColoplast A/SLJE2023-01-20
05701780271066KolibriColoplast A/SLJE2023-01-20
05701780271097KolibriColoplast A/SLJE2023-01-20
05701780271127KolibriColoplast A/SLJE2023-01-20
05701780271165KolibriColoplast A/SLJE2023-01-20
05701780271189KolibriColoplast A/SLJE2023-01-20
05701780271219KolibriColoplast A/SLJE2023-01-20
05701780271240KolibriColoplast A/SLJE2023-01-20
05701780271271KolibriColoplast A/SLJE2023-01-20
05701780271318KolibriColoplast A/SLJE2023-01-20
05701780271332KolibriColoplast A/SLJE2023-01-20
05701780271363KolibriColoplast A/SLJE2023-01-20
05701780271417KolibriColoplast A/SLJE2023-01-20
05701780271448KolibriColoplast A/SLJE2023-01-20
05701780271462KolibriColoplast A/SLJE2023-01-20
05701780271509KolibriColoplast A/SLJE2023-01-20
05701780271547KolibriColoplast A/SLJE2023-01-20
05701780271592KolibriColoplast A/SLJE2023-01-20
05701780271622KolibriColoplast A/SLJE2023-01-20
05701780271646KolibriColoplast A/SLJE2023-01-20
05701780271677KolibriColoplast A/SLJE2023-01-20
05701780271714KolibriColoplast A/SLJE2023-01-20
05701780271745KolibriColoplast A/SLJE2023-01-20
05701780271783KolibriColoplast A/SLJE2023-01-20
05701780271813KolibriColoplast A/SLJE2023-01-20