FDA.reportPublic FDA data

Magic3™ Hydrophilic Intermittent Catheter, Male

Primary DI
00801741072659
Brand
Magic3™ Hydrophilic Intermittent Catheter, Male
Company
Rochester Medical Corporation
Model
53614GS
Catalog number
53614GS
Device description
Magic3™ Hydrophilic Intermittent Catheter, Male
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KODCATHETER, UROLOGICAL
OHRCatheter care tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741072656PackageGS150In Commercial Distribution
00801741072659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174107265610801741072656
00801741072659008017410726598017410726590801741072659

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge14French
Length16Inch

Contacts#

Phone, Email table
PhoneEmail
+1(800)243-3315medical.services@crbard.com

Regulatory Flags#

DUNS number
605440718
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741072666Magic3™ Hydrophilic Intermittent Catheter, Male53616GS53616GS2016-09-27
00801741011061FemSoft® Insert Female Urethral Insert71201712012015-03-30
00801741011078FemSoft® Insert Female Urethral Insert71202712022015-03-30
00801741011085FemSoft® Insert Female Urethral Insert71203712032015-03-27
00801741011092FemSoft® Insert Female Urethral Insert72201722012015-03-27
00801741011108FemSoft® Insert Female Urethral Insert72202722022015-03-27
00801741011115FemSoft® Insert Female Urethral Insert72203722032015-03-30
00801741072598Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Female51514S51514S2016-09-26
00801741072697Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Male53512GS53512GS2016-09-27
00801741072703Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Male53514GS53514GS2016-09-27
10801741011068FemSoft® Insert Female Urethral Insert71201712012015-03-30
10801741011075FemSoft® Insert Female Urethral Insert71202712022015-03-30
10801741011082FemSoft® Insert Female Urethral Insert71203712032015-03-27
10801741011099FemSoft® Insert Female Urethral Insert72201722012015-03-27
10801741011105FemSoft® Insert Female Urethral Insert72202722022015-03-27
10801741011112FemSoft® Insert Female Urethral Insert72203722032015-03-30
00801741011122FemSoft® Insert Female Urethral Insert70200702002015-03-27
10801741072496Magic3™ Hydrophilic Intermittent Catheter, Female51614S51614S2016-09-26
10801741072595Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Female51514S51514S2016-09-26
10801741072656Magic3™ Hydrophilic Intermittent Catheter, Male53614GS53614GS2016-09-27

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