FDA.reportPublic FDA data

Avaline Medical NJ LLC

Primary DI
00810077211656
Brand
Avaline Medical NJ LLC
Company
Avaline Medical NJ Limited Liability Company
Model
VKKSC02
Catalog number
VKKSC02
Device description
Calculi Strainer / Kidney Stone Collector (2 Pack)
Published
2021-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNPURINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNPUrinalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810077211656PrimaryGS10
00810077211649Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810077211656008100772116568100772116560810077211656
00810077211649008100772116498100772116490810077211649

GMDN Terms#

Term, Definition table
TermDefinition
Urine strainerA device designed to collect stones (calculi) from urine during normal micturition (urination). It is typically designed as a sieve-like container with handles for holding and emptying, and is typically mounted into a funnel/holder system that may be attached to a dedicated treatment table or chair. The collected stones are typically sent to the clinical laboratory for examination and composition determination to facilitate patient diagnosis and/or therapy. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(732)813-7799jstein@avalinemedical.com

Regulatory Flags#

DUNS number
079767953
Device count
2
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810077219904Avaline Medical NJ LLCVKAEP202023-11-04
00810077219911Avaline Medical NJ LLCVKAEP402023-11-04
00810077219928Avaline Medical NJ LLCVKAEP602023-11-04
00810077219935Avaline Medical NJ LLCVKAEP1202023-11-04
00810077219942Avaline Medical NJ LLCVKAEP2402023-11-04
00810077219959Avaline Medical NJ LLCVKAEP4802023-11-04
00810124536794Avaline Medical NJ LLCVK97245VK972452025-12-05
00810124536831Avaline Medical NJ LLCVK97223VK972232025-12-05
00810124536855Avaline Medical NJ LLCVK15236VK152362025-12-05
00810124536886Avaline Medical NJ LLCVK15296VK152962025-12-05
00810124536787Avaline Medical NJ LLCVK97245VK972452025-12-05
00810124536824Avaline Medical NJ LLCVK97223VK972232025-12-05
00810124536848Avaline Medical NJ LLCVK15236VK152362025-12-05
00810124536879Avaline Medical NJ LLCVK15296VK152962025-12-05
00810124536909Avaline Medical NJ LLCVK69576VK695762025-12-05
00810124536923Avaline Medical NJ LLCVK45915VK459152025-12-05
00810124531843Avaline Medical NJ LLC1lb C-Rollx32025-09-03
00810124532116Avaline Medical NJ LLCOEP x252025-09-03
00810124532123Avaline Medical NJ LLCOEP x502025-09-03
00810124532130Avaline Medical NJ LLCOEP x1002025-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20748426261745Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261758Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261765Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261772Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261789Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261796Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261802Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261819Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261826Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261833Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261840Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261857Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261864Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261871Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261888Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
00748426261895Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261752Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261769Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261776Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261783Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261790Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261806Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261813Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261820Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261837Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261844Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261851Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261868Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261875Medline-MicrotekMicrotek Medical LLCFNP2026-01-28
20748426261882Medline-MicrotekMicrotek Medical LLCFNP2026-01-28