DynaSafety Cotton-Tipped Applicators in Sealed Vial,3"

GUDID 00810180840163

Dynarex Corporation

General-purpose absorbent tip applicator/swab, single-use
Primary Device ID00810180840163
NIH Device Record Keybef025bf-acce-4c32-a5f9-6f1ace8c8c1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaSafety Cotton-Tipped Applicators in Sealed Vial,3"
Version Model Number4307
Company DUNS008124539
Company NameDynarex Corporation
Device Count100
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
GS100616784430713 [Primary]
GS100616784430737 [Package]
Contains: 00616784430713
Package: Case [50 Units]
In Commercial Distribution
GS100810180840163 [Unit of Use]

FDA Product Code

KXFApplicator, Absorbent Tipped, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-19
Device Publish Date2024-11-11

Devices Manufactured by Dynarex Corporation

00810180840781 - LabChoice Transfer Pipettes, Small Bulb, 3mL Transparent 2025-01-03 Sterile-Eo
00810180840798 - LabChoice Serological Pipettes, 1mL, Sterile 2025-01-02 Sterile-R
00810180840804 - LabChoice Serological Pipettes, 2mL, Sterile2025-01-02 Sterile-R
00810180840811 - LabChoice Serological Pipettes, 5mL, Sterile2025-01-02 Sterile-R
00810180840774 - LabChoice Transfer Pipettes, Small Bulb, 3mL2025-01-02 Non-Sterile
00840117340398 - Resp-O2 Disposable Guedel Airway, 90 mm, Adult Medium, Yellow2024-12-30
00840117340404 - Resp-O2 Disposable Guedel Airway, 100 mm, Adult Large, Red2024-12-30
00840117340411 - Resp-O2 Disposable Guedel Airway, 110 mm, Adult X-Large, Orange 2024-12-30

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.