FDA.reportPublic FDA data

Assured

Primary DI
00639277526489
Brand
Assured
Company
Dollar Tree Mdsg Chesapeake Ci
Model
275152
Device description
Non-Stick Pads, 2 in x 3 in (5 cm x 7.6 cm)
Published
2020-05-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20639277526483PackageGS124Not in Commercial Distribution
00639277526489PrimaryGS10
60639277526481Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2063927752648320639277526483
00639277526489006392775264896392775264890639277526489
6063927752648160639277526481

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; in some cases, the device’s packaging may be used as a disposable tray. This is a single-use device.

Regulatory Flags#

DUNS number
610322518
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00639277288912Assured 1511272016-09-19
00639277079596Assured2173512020-05-29
00639277288929Assured 1595032016-09-19
00639277182883Assured2270232020-05-29
00639277232540Assured2343912020-05-29
00639277079633Assured2173382020-05-29
00639277082244Assured2180362020-05-29
00639277082275Assured2180392020-05-29
00639277152787Assured2255712020-05-29
00639277182845Assured2270192020-05-29
00639277230690Assured2333112020-05-29
20639277079590Assured2173512020-05-29
20639277079637Assured2173382020-05-29
20639277082248Assured2180362020-05-29
20639277082279Assured2180392020-05-29
20639277152781Assured2255712020-05-29
20639277182849Assured2270192020-05-29
20639277182887Assured2270232020-05-29
20639277230694Assured2333112020-05-29
20639277232544Assured2343912020-05-29

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