FDA.reportPublic FDA data

Assured

Primary DI
00639277079596
Brand
Assured
Company
Dollar Tree Mdsg Chesapeake Ci
Model
217351
Device description
Rolled Gauze, 3 in x 2.5 yds (7.6 cm x 2.29 m) unstretched
Published
2020-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
20639277079590PackageGS124In Commercial Distribution
00639277079596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2063927707959020639277079590
00639277079596006392770795966392770795960639277079596

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze roll/sheetA device in the form of a long length of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Regulatory Flags#

DUNS number
610322518
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00639277526489Assured2751522020-05-29
00639277288912Assured 1511272016-09-19
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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