FDA.reportPublic FDA data

C3

Primary DI
08519520073347
Brand
C3
Company
PERSONAL MEDICAL CORP.
Model
Male Continence Device
Catalog number
910300
Published
2018-08-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHAClamp, Penile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHAClamp, PenileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08519520073347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08519520073347085195200733478519520073347

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence penis clamp, single-useA male urinary incontinence device designed to gently compress the penis, either the proximal shaft or the glans penis, to occlude the urethra and prevent involuntary urination/dribbling for men who are incontinent of the bladder. It is typically made of plastic materials and is designed as an adjustable, two hinged, self-retaining lever clamp with foam rubber inserts; the user can typically adjust the tension to suit their penis size and needs. It is removed by the user when voiding and then reapplied. This is a single-use device which is discarded when soiled.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
425-242-6373info@personalmed.com

Regulatory Flags#

DUNS number
078511333
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08519520070009IVS-2Intravaginal Sensor45252016-10-18
08519520070010MEPAnal Sensor45202016-10-18
08519520070018EvaCare PessaryDish Pessary with SupportDSHS2016-12-06
08519520070025EvaCare PessaryCube Pessary with DrainCUD2016-12-06
08519520070063SenseRx -- Anal/Small Vaginal and Vaginal EMG4510C4510C2016-12-06
08519520070070IVS-2Intravaginal Sensor45252016-12-06
08519520070087MEPAnal Sensor45202016-12-06
08519520070148EvaCare PessaryGellhorn PessaryGD2016-12-06
08519520070032Personal Medical Corp2 Channel MEP Adaptor4695G2016-12-06
08519520070034Personal Medical Corp2 Channel MEP Adaptor4695G2016-10-31
08519520070001EvaCare PessaryRingR2016-10-10
08519520070007EvaCare PessaryRing w/ SupportRS2016-10-10
08519520070049EvaCare PessaryRing w/ SupportRS2016-12-06
08519520070003SenseRx -- Anal/Small Vaginal and Vaginal EMG4510C4510C2016-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613105082MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-08-01
04049047064947GimmiGimmi GmbHFHA2025-05-20
00194613031305MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-03-21
00194613103484MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-03-21
00194613106959MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-03-21
00194613111113MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2025-03-21
00194613061531MSI Precision Specialty InstrumentsMed Saver, Inc.FHA2024-08-15
00887482075333Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.FHA2024-08-15
04049197264655RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFHA2024-06-28
04049197264662RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFHA2024-06-28
00840183523008BR Surgical, LLCBR Surgical, LLCFHA2024-06-10
00653599002179KindKlampARGENTUM MEDICAL, LLCFHA2024-02-07
G586UR96208880Novo SurgicalNOVO SURGICAL, INC.FHA2023-12-18
00842962125977HNM MEDICALHNM STAINLESS, LLC.FHA2023-04-12
B974ZC1100PENIS CLAMPDR.FRIGZ INTERNATIONAL(PVT)LTD,FHA2022-11-21
08800064400004Jeato Incontinence ClampJeato Med. CO., Ltd.FHA2022-11-14
08800064400103Jeato 7 Incontinence Clamp Jeato Med. CO., Ltd.FHA2022-11-14
00842331127403Novo Surgical Inc. NOVO SURGICAL, INC.FHA2022-11-09
00887482076101Symmetry VasASPEN SURGICAL PRODUCTS, INC.FHA2022-09-21
00887482076194Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.FHA2022-09-21
00653599001660KindKlampARGENTUM MEDICAL, LLCFHA2021-09-20
00190660018443Ambler SurgicalAMBLER SURGICAL CORP.FHA2021-01-04
04046826062989MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFHA2020-09-24
04046826062996MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFHA2020-09-24
00801741049002Penile ClampC. R. Bard, Inc.FHA2020-09-22
00801741050961Penile ClampC. R. Bard, Inc.FHA2020-09-22
00801741072741Incontinence ClampC. R. Bard, Inc.FHA2020-09-04
00801741072758Incontinence ClampC. R. Bard, Inc.FHA2020-09-04
00801741072765Incontinence ClampC. R. Bard, Inc.FHA2020-09-04
04038653039326AESCULAPAesculap AGFHA2020-04-20