FDA.reportPublic FDA data

Magic3™ Antibacterial Hydrophilic Intermittent Catheter, Male

Primary DI
00801741072697
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
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
Length16Inch

Contacts#

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

Regulatory Flags#

DUNS number
605440718
Device count
1
Premarket exempt
true
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956385054CARDINAL HEALTHCardinal Health 200, LLCOHR2026-04-27
10198956214569CARDINAL HEALTHCardinal Health 200, LLCOHR2025-11-28
10198956094376CARDINAL HEALTHCardinal Health 200, LLCOHR2025-08-25
10197106910979CARDINAL HEALTHCardinal Health 200, LLCOHR2025-04-23
10197344148981MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-07
10197344148998MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-02
10197344149001MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-02
10197106963685CARDINAL HEALTHCardinal Health 200, LLCOHR2025-03-14
10198459028793Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2024-07-29
10809160429389Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OHR2024-07-10
10198459044588Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2024-06-23
10195327610999MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-25
10193489834482MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05
10193489939262MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05
10080196997084MedlineMEDLINE INDUSTRIES, INC.OHR2023-12-28
10195327468880Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-12-21
10653160995791Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OHR2023-12-21
10850053289191SURGYCOSurgyco LLCOHR2023-12-15
10195327443023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-15
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
10195327503192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-09-17
10610075177063ApogeeHOLLISTER INCORPORATEDOHR2023-08-22
10195327476946Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-08-13
10195327245474Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-07-29
10653160995517Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OHR2023-07-29
10195327195236MedlineMEDLINE INDUSTRIES, INC.OHR2023-06-08
10195327242862MedlineMEDLINE INDUSTRIES, INC.OHR2023-06-08
10653160995067Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OHR2023-04-30