FDA.reportPublic FDA data

Avaline Medical NJ LLC

Primary DI
00810077212936
Brand
Avaline Medical NJ LLC
Company
Avaline Medical NJ Limited Liability Company
Model
EMWSC6x50
Catalog number
EMWSC6x50
Device description
6 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
Rx
false
OTC
false
Sterile
false
Single use
false

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
00810077210246PrimaryGS10
00810077212738PrimaryGS10
00810077213100PrimaryGS10
00810077212936Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810077210246008100772102468100772102460810077210246
00810077212738008100772127388100772127380810077212738
00810077213100008100772131008100772131000810077213100
00810077212936008100772129368100772129360810077212936

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079767953
Device count
5
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
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
00810077210536Avaline Medical NJ LLCkueel5kueel52021-05-10
00810077210543Avaline Medical NJ LLCkuwml5kuwml52021-05-10
00850025452106Avaline Medical NJ LLCkuwml10kuwml102021-05-10
00850025452113Avaline Medical NJ LLCkuwmxl10kuwmxl102021-05-10
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

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