FDA.reportPublic FDA data

FifthPulse

Primary DI
00810084936931
Brand
FifthPulse
Company
Jeg & Sons Inc.
Model
12 Pack
Catalog number
FMN100530
Device description
Stretch Gauze Bandage
Published
2022-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
00810084936931PrimaryGS10
00810084938379Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810084936931008100849369318100849369310810084936931
00810084938379008100849383798100849383790810084938379

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll/sheetA device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and 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
789973646
Device count
12
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810084936887FifthPulse5 PackFMN1005252022-12-16
00810084936894FifthPulse10 PackFMN1005262022-12-16
00810084938355FifthPulse10 PackFMN1005262022-12-16
00810084936900FifthPulse10 PackFMN1005272022-12-16
00810084936917FifthPulse20 PackFMN1005282022-12-16
00810084938362FifthPulse20 PackFMN1005282022-12-16
00850026094305FifthPulseFP050-TS2021-07-01
00850026094312FifthPulseFP050-L2021-07-01
00850028714492FifthPulseFP100-TS2021-07-01
00850028714508FifthPulseFP100-L2021-07-01
00850026094299FifthPulseFP607-G2021-07-01
00850028714614FifthPulseFP607-GK2021-07-01
00683346554989WeCare3-Ply BlueWMN1000042022-12-16
00683346554996WeCare3-Ply BlueWMN1000052022-12-16
00810084932087WeCareNavy - AdultsWMN1001412022-12-16
00810084932094WeCareDark Gray - AdultsWMN1001422022-12-16
00810084932810WeCareOcean Tones - AdultsWMN1001232022-12-16
00810084932827WeCareEarth Tones - AdultsWMN1001262022-12-16
00810084932834WeCareAssorted Tie Dye - AdultsWMN1001272022-12-16
00810084939307WeCareNavy - AdultsWMN1001412022-12-16

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