FDA.reportPublic FDA data

Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Male

Primary DI
10801741072694
Brand
Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Male
Company
Rochester Medical Corporation
Model
53512GS
Catalog number
53512GS
Device description
Magic3™ Antibacterial 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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHRCatheter care tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741072694PackageGS150In Commercial Distribution
00801741072697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174107269410801741072694
00801741072697008017410726978017410726970801741072697

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 Gauge12French

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
605440718
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741072659Magic3™ Hydrophilic Intermittent Catheter, Male53614GS53614GS2016-09-27
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

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Primary DI, Brand, Company table
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10197344148981MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-07
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10197106963685CARDINAL HEALTHCardinal Health 200, LLCOHR2025-03-14
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10195327443108Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-15
10197106420386CARDINAL HEALTHCardinal Health 200, LLCOHR2023-10-12
10195327512514Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-01
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