FDA.reportPublic FDA data

Avaline Medical NJ LLC

Primary DI
00810077213094
Brand
Avaline Medical NJ LLC
Company
Avaline Medical NJ Limited Liability Company
Model
EMWSC4x50
Catalog number
EMWSC4x50
Device description
4 inch Elastic Bandage Wrap with Self-Closure x50
Published
2022-03-05
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
FQMBANDAGE, ELASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810077213094PrimaryGS10
00810077212929Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810077213094008100772130948100772130940810077213094
00810077212929008100772129298100772129290810077212929

GMDN Terms#

Term, Definition table
TermDefinition
Ankle binder, reusableA strip or roll of fabric or plastic material designed to be wrapped around the ankle to help stabilize and support the joint. It does not include a rigid support (i.e., not an ankle/foot orthosis) and is not a tubular support bandage. This is a reusable device after appropriate cleaning.

Contacts#

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

Regulatory Flags#

DUNS number
079767953
Device count
50
DM exempt
true
Premarket exempt
true
Kit
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810077211694Avaline Medical NJ LLCvk02muvk02mu2021-10-15
00810124537616VaklyVK346952026-07-16
00810124537647VaklyVK617402026-07-10
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

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