FDA.reportPublic FDA data

O'Neil Intermittent Urinary Catheter

Primary DI
09350902001232
Brand
O'Neil Intermittent Urinary Catheter
Company
GO MEDICAL INDUSTRIES PTY. LTD.
Model
16 Gauge
Catalog number
ONSM16
Published
2017-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBMCatheter, Urethral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993651000O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETERSc Hennig Enterprises Europe Srl1999-12-23GBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09350902001232PackageGS1200In Commercial Distribution
09350902001225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09350902001232093509020012329350902001232
09350902001225093509020012259350902001225

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral catheterization kitA collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories (e.g., gloves, drapes, tray) intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the user to provide short-term, episodic urine drainage. It is typically pre-lubricated or coated with, made of, or includes materials/substances that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) commonly known as Teflon, or glass]; it might also be coated with or include antimicrobial materials/substances to help prevent infection of the urinary tract. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
757634266
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09350902000396Flow Control TubingFCT 10mL/5minFCT10-5m2016-09-24
09350902000426Flow Control TubingFCT 10mL/15minFCT10-15m2016-09-24
09350902000457Flow Control TubingFCT 10mL/30minFCT10-30m2016-09-24
09350902000488Flow Control TubingFCT 10mL/60minFCT10-60m2016-09-24
09350902000518Flow Control TubingFCT 10mL/2hFCT10-2h2016-09-24
09350902000549Flow Control TubingFCT 10mL/4hFCT10-4h2016-09-24
09350902000570Flow Control TubingFCT 10mL/6hFCT10-6h2016-09-24
09350902000600Flow Control TubingFCT 10mL/8hFCT10-8h2016-09-24
09350902000631Flow Control TubingFCT 10mL/12hFCT10-12h2016-09-24
09350902000662Flow Control TubingFCT 10mL/24hFCT10-24h2016-09-24
09350902000693Flow Control TubingFCT 10mL/48hFCT10-48h2016-09-24
09350902000723Flow Control TubingFCT 10mL/72hFCT10-72h2016-09-24
09350902000754Flow Control TubingFCT 30mL/5minFCT30-5m2017-05-16
09350902000785Flow Control TubingFCT 30mL/15minFCT30-15m2017-05-16
09350902000815Flow Control TubingFCT 30mL/30minFCT30-30m2017-05-16
09350902000846Flow Control TubingFCT 30mL/60minFCT30-60m2017-05-16
09350902000877Flow Control TubingFCT 30mL/2hFCT30-2h2017-05-16
09350902000907Flow Control TubingFCT 30mL/4hFCT30-4h2017-05-16
09350902000938Flow Control TubingFCT 30mL/6hFCT30-6h2017-05-16
09350902000969Flow Control TubingFCT 30mL/8hFCT30-8h2017-05-16

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