FDA.reportPublic FDA data

Dealmed

Primary DI
00817415021083
Brand
Dealmed
Company
DEALMED MEDICAL SUPPLIES LLC
Model
783032
Catalog number
783032
Device description
"Gauze Pad Woven N/S 3"" x 3"" 8-Ply, 200/Bx"
Published
2020-12-04
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
10817415021080PackageGS120In Commercial Distribution
00817415021083PrimaryGS10
00817415020925Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081741502108010817415021080
00817415021083008174150210838174150210830817415021083
00817415020925008174150209258174150209250817415020925

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
068586441
Device count
200
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817415020086Dealmed7875307875302022-08-29
00859140003125Dealmed7875207875202022-08-29
10817415021653Dealmed7831327831322021-09-30
10817415021844DEALMED7838227838222021-09-17
00859140003750Dealmed8591400037577830432020-09-11
00859140003798Dealmed7838047838042020-12-04
00817415021861Dealmed7864017864012021-04-26
00817415021878Dealmed7864027864022021-04-26
00817415021885Dealmed7864037864032021-04-26
00817415023049Dealmed7864047864042022-07-18
00817415023087Dealmed7864087864082022-07-28
00817415023063Dealmed7864067864062022-07-28
00817415020468Dealmed7836197836192020-12-04
00817415020512Dealmed7835037835032020-12-04
00817415021069Dealmed7885257885252021-06-11
00817415022370Dealmed7832527832522022-08-29
00817415022387Dealmed7832537832532022-08-29
00817415022394Dealmed7832547832542022-08-29
00817415022400Dealmed8079458079452021-10-25
00859140003545Dealmed7830447830442020-12-04

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