FDA.reportPublic FDA data

United Urologics Closed System Catheter

Primary DI
00818016020103
Brand
United Urologics Closed System Catheter
Company
UNITED UROLOGICS INC
Model
UU16R
Published
2017-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KODCatheter, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818016020106PackageGS1100In Commercial Distribution
00818016020103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081801602010610818016020106
00818016020103008180160201038180160201030818016020103

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080428707
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818016020314United Urologics Insertion KitUUIK012017-03-22
00818016020635United Urologics Closed System CatheterUU16R2017-03-22
00818016020109United Urologics Closed System CatheterUU16R2019-06-17
10818016020311United Urologics Insertion KitUUIK012017-03-22
00818016020017United Urologics Closed System Catheter KitUU062017-03-22
00818016020024United Urologics Closed System CatheterUU082017-03-22
00818016020031United Urologics Closed System CatheterUU102017-03-22
00818016020048United Urologics Closed System CatheterUU122017-03-22
00818016020055United Urologics Closed System CatheterUU142017-03-22
00818016020062United Urologics Closed System CatheterUU162017-03-22
00818016020079United Urologics Closed System CatheterUU182017-03-22
00818016020086United Urologics Closed System CatheterUU12R2017-03-22
00818016020093United Urologics Closed System CatheterUU14R2017-03-22
00818016020116United Urologics Closed System CatheterUU12S2017-03-22
00818016020123United Urologics Closed System CatheterUU14S2017-03-29
00818016020130United Urologics Closed System CatheterUU12C2017-03-22
00818016020147United Urologics Closed System CatheterUU14C2017-03-22
00818016020154United Urologics Closed System CatheterUU16C2017-03-22
00818016020161United Urologics Closed System Catheter KitUU06K2017-03-22
00818016020178United Urologics Closed System Catheter KitUU08K2017-03-22

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Primary DI, Brand, Company table
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