Cotton Balls

GUDID 20749915000555

Cotton Balls-Strung 3/4"

AMERICAN SURGICAL COMPANY, LLC

Cotton ball Cotton ball
Primary Device ID20749915000555
NIH Device Record Key290beeca-065b-4495-8cbd-6322742dbc7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCotton Balls
Version Model Number30-03
Company DUNS151054954
Company NameAMERICAN SURGICAL COMPANY, LLC
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110749915000558 [Unit of Use]
GS120749915000555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GDYGauze/Sponge, Internal, X-Ray Detectable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-25
Device Publish Date2016-06-07

On-Brand Devices [Cotton Balls]

30749915000613Cotton Balls-Non-Strung 1/4"
30749915000538Cotton Balls-Strung 3/8"
20749915000685Cotton Balls-Non-Strung 1/8"
20749915000678Cotton Balls-Non-Strung 2"
20749915000661Cotton Balls-Non-Strung 1.25"
20749915000654Cotton Balls-Non-Strung 1"
20749915000647Cotton Balls-Non-Strung 3/4"
20749915000630Cotton Balls-Non-Strung 1/2"
20749915000623Cotton Balls-Non-Strung 3/8"
20749915000609Cotton Balls-Strung 1/8"
20749915000593Cotton Balls-Strung 2"
20749915000586Cotton Balls-Strung 1.25"
20749915000562Cotton Balls-Strung 1"
20749915000555Cotton Balls-Strung 3/4"
20749915000548Cotton Balls-Strung 1/2"
20749915000517Cotton Balls-Strung 1/4"

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