ULINE BULLET EARPLUGS REFILL

GUDID 30850015055493

ULINE, INC.

Earplugs, single-use
Primary Device ID30850015055493
NIH Device Record Key12297496-3cd6-4c0a-9195-144a65ae40b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameULINE BULLET EARPLUGS REFILL
Version Model NumberS-25946
Company DUNS039612668
Company NameULINE, INC.
Device Count600
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850015055706 [Unit of Use]
GS110850015055703 [Primary]
GS130850015055493 [Package]
Contains: 10850015055703
Package: [10 Units]
In Commercial Distribution

FDA Product Code

EWDProtector, Hearing (Insert)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-21
Device Publish Date2024-05-13

On-Brand Devices [ULINE BULLET EARPLUGS REFILL]

30850015055233S-24617
30850015055493S-25946

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.