Unflavored Oral Swab, For Professional and Hospital Use

GUDID 00840117348813

Individually Wrapped

Dynarex Corporation

Oral care swab
Primary Device ID00840117348813
NIH Device Record Keybdca70cb-d83a-433b-b5dd-fae2400b5b8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnflavored Oral Swab, For Professional and Hospital Use
Version Model Number1218
Company DUNS008124539
Company NameDynarex Corporation
Device Count250
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810180842563 [Unit of Use]
GS100840117348813 [Primary]
GS100840117348820 [Package]
Package: Case [4 Units]
In Commercial Distribution

FDA Product Code

KXFApplicator, Absorbent Tipped, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2026-01-29
Device Publish Date2019-09-03

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