FDA.reportPublic FDA data

Avaline Medical NJ LLC

Primary DI
00810077213247
Brand
Avaline Medical NJ LLC
Company
Avaline Medical NJ Limited Liability Company
Model
VKBLKDB55
Catalog number
VKBLKDB55
Device description
"Vakly 2-Ply, Dental Bibs/Tattoo Bibs/Professional Towels/Professional Bib - 13'' x 18"", Black 55"
Published
2022-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHRABSORBER, SALIVA, PAPER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHRAbsorber, Saliva, PaperDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810077213247PrimaryGS10
00810077210901Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810077213247008100772132478100772132470810077213247
00810077210901008100772109018100772109010810077210901

GMDN Terms#

Term, Definition table
TermDefinition
Dental bibA non-sterile device intended to be worn by a patient during a dental examination or treatment procedure to function as a barrier to soiling and cross-contamination. It typically consists of a shaped piece of natural and/or synthetic material intended to be fastened around the neck and cover the front side of the upper body. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
079767953
Device count
55
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
00840456217696JMUJMU DENTAL, INCKHR2026-06-05
00840456222188JMUJMU DENTAL, INCKHR2026-06-05
00840456222195JMUJMU DENTAL, INCKHR2026-06-05
00840456223000JMUJMU DENTAL, INCKHR2026-06-05
00840456223017JMUJMU DENTAL, INCKHR2026-06-05
00840456201756JMUJMU DENTAL, INCKHR2026-05-27
00840456201763JMUJMU DENTAL, INCKHR2026-05-27
00840456201770JMUJMU DENTAL, INCKHR2026-05-27
00840456201787JMUJMU DENTAL, INCKHR2026-05-27
00840456201794JMUJMU DENTAL, INCKHR2026-05-27
00840456221020JMUJMU DENTAL, INCKHR2026-05-27
10371347011439Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011446Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011453Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011460Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011477Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011484Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011491Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011507Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
50732224004650Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004704Sani-Tab Chain-Free Polyback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004711Sani-Tab Chain-Free Polyback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004728Sani-Tab Chain-Free Polyback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004735Sani-Tab Chain-Free Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004742Sani-Tab Chain-Free Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004759Sani-Tab Chain-Free Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004766Sani-Tab Chain-Free Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004773Professional Regular TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004780Professional Regular TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004797Professional Regular TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17