FDA.reportPublic FDA data

Avaline Medical NJ LLC

Primary DI
00810124531294
Brand
Avaline Medical NJ LLC
Company
Avaline Medical NJ Limited Liability Company
Model
NAP2X3x1
Catalog number
NAP2X3x1
Device description
2x3 Non-Adherent Pads
Published
2023-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810124530747PrimaryGS10
00810124530754PrimaryGS10
00810124530761PrimaryGS10
00810124531232PrimaryGS10
00810124531249PrimaryGS10
00810124531256PrimaryGS10
00810124531263PrimaryGS10
00810124531270PrimaryGS10
00810124531287PrimaryGS10
00850025452519PrimaryGS10
00810124531294Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810124530747008101245307478101245307470810124530747
00810124530754008101245307548101245307540810124530754
00810124530761008101245307618101245307610810124530761
00810124531232008101245312328101245312320810124531232
00810124531249008101245312498101245312490810124531249
00810124531256008101245312568101245312560810124531256
00810124531263008101245312638101245312630810124531263
00810124531270008101245312708101245312700810124531270
00810124531287008101245312878101245312870810124531287
00850025452519008500254525198500254525190850025452519
00810124531294008101245312948101245312940810124531294

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079767953
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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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