FDA.reportPublic FDA data

KindKlamp

Primary DI
M456200030
Brand
KindKlamp
Company
BIODERM, INC.
Model
20003
Device description
KindKlamp, Penile Clamp
Published
2020-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00653599000007PrimaryGS10
M456200030SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653599000007006535990000076535990000070653599000007

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence penis clamp, reusableA 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. The device is washed/disinfected at regular intervals to maintain hygiene. It is normally available [non-prescription] over-the-counter (OTC). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-864-6755CustomerCare@BioDermInc.com

Regulatory Flags#

DUNS number
114773653
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
10653599001971CathGrip51023NWCA2024-03-20
10653599002015CathGrip51301NACA2024-03-20
10653599002022CathGrip51301LPNACA2024-03-20
10653599002121CathGrip51350NSNACA2024-03-20
10653599002138CathGrip53002NSNACA2024-03-20
10653599002145CathGrip54002NSNACA2024-03-20
10653599002152CathGrip54003NSNACA2024-03-20
10653599001995CathGrip51300NACA2024-03-08
10653599002008CathGrip51300LPNACA2024-03-08
10653599001872CathGrip51023NSNWLA2024-02-07
10653599001896CathGrip51250LPNSNALA2024-02-07
10653599001902CathGrip51300LPNSNALA2024-02-07
10653599001940Men's Liberty Acute21026152024-02-07
10653599001988CathGrip51250NACA2024-02-07
10653599002039CathGrip51350NACA2024-02-07
10653599002053CathGrip51023NSNWCA2024-02-07
10653599002060CathGrip51250NSNACA2024-02-07
10653599002077CathGrip51250LPNSNACA2024-02-07
10653599002084CathGrip51300NSNACA2024-02-07
10653599002091CathGrip51300LPNSNACA2024-02-07

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