FDA.reportPublic FDA data

Avaline Medical NJ LLC

Primary DI
00810077216422
Brand
Avaline Medical NJ LLC
Company
Avaline Medical NJ Limited Liability Company
Model
1/4 PS x12
Catalog number
1/4 PS x12
Device description
Packing Strip 1/4 inch x 12
Published
2022-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, wound, occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810077216422PrimaryGS10
00810077216439Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810077216422008100772164228100772164220810077216422
00810077216439008100772164398100772164390810077216439

GMDN Terms#

Term, Definition table
TermDefinition
Gauze strip, non-antimicrobialA thin length of non-medicated woven material (e.g., cotton, cellulose) primarily designed to pack draining wounds to absorb exudates; it does not include an antimicrobial agent. It may be soaked with medication (not included) before application. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
079767953
Device count
12
DM exempt
true
Premarket exempt
true
No natural rubber latex
true

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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