FDA.reportPublic FDA data

VASECTOMY REVERSAL APPROXIMATOR CLAMP

Primary DI
00192896045637
Brand
VASECTOMY REVERSAL APPROXIMATOR CLAMP
Company
SONTEC INSTRUMENTS, INC.
Model
516-741
Catalog number
516-741
Device description
VASECTOMY REVERSAL APPROXIMATOR CLAMP
Published
2018-09-18
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
GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896045637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896045637001928960456371928960456370192896045637

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.

Device Sizes#

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

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00192896123762TAVR Removal Set2400-200-SET2400-200-SET2026-09-18
00192896123779Waever Chalazion Forceps14-988014-98802026-09-18
00192896123786Prince Trachoma Eye Forceps14-968014-96802026-09-18
00192896123632Adson Dressing Forceps140-299S140-299S2026-08-27
00192896123649Converse Scissors460-156L460-156L2026-08-27
00192896123656Ferguson Abdominal Scissors110-287110-2872026-08-27
00192896123663Meyerding Finger Retractor205-856Q205-856Q2026-08-27
00192896123670Meyerding Finger Retractor205-857Q205-857Q2026-08-27
00192896122499Cartilage Graft Cutter350-842350-8422025-11-21
00192896122048Ceramitec Universal Klick Ferris Smith Rongeur Shaft404-312B404-312B2026-08-25
00192896123564Castroviejo Corneal Scissors13-2540F13-2540F2026-07-27
00192896123571Adson Needle Holding Forceps140-300140-3002026-07-27
00192896123557Debakey Neonatal Clamp2100-580B2100-580B2026-07-10
00192896078819FERRIS-SMITH KERRISON404-682404-6822018-09-20
00192896117129Meeker Hemostatic Forceps2200-440Q2200-440Q2024-03-25
00192896123502Stefan Bone Holding Forceps1103-011Q1103-011Q2026-06-24
00192896123519Rochester Carmalt Forceps1100-150L1100-150L2026-06-24
00192896123526Rochester Carmalt Forceps1100-150LQ1100-150LQ2026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433017MillenniumAvalign Technologies, Inc.GDJ2026-10-01
00190776433109MillenniumAvalign Technologies, Inc.GDJ2026-10-01
00190776432584MillenniumAvalign Technologies, Inc.GDJ2026-09-28
00190776430993MillenniumAvalign Technologies, Inc.GDJ2026-09-18
00190776426705MillenniumAvalign Technologies, Inc.GDJ2026-08-19
00850088713459PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00850088713466PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00850088713527PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00190776424497MillenniumAvalign Technologies, Inc.GDJ2026-08-07
03701089543286AMPLITUDEAMPLITUDE SASGDJ2026-07-29
00190776422196MillenniumAvalign Technologies, Inc.GDJ2026-07-28
B382SD9055891030Surgical DirectSurgical Direct, Inc.GDJ2026-07-28
B382SD905589105T0Surgical DirectSurgical Direct, Inc.GDJ2026-07-28
00859261006265VBAS Extension ArmVYCOR MEDICAL, INC.GDJ2026-07-27
04059453072832Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2026-07-13
00850083275150Intrace USAPILOTIS TECH LLCGDJ2026-07-03
B8034906020ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906040ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906060ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906080ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906100ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906180ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906200ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906220ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906240ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906260ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
04052536085651neon3Ulrich GmbH & Co. KGGDJ2026-06-08
B7685610100Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2025-03-27
B7685610460Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2025-01-10
B7685610500Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2025-01-10