Earplugs

GUDID 00816472023252

Earplugs (25 sets)

Intersurgical Incorporated

Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use Earplugs, single-use
Primary Device ID00816472023252
NIH Device Record Key74ad4b9d-19e5-468c-aa95-217668c6cb49
Commercial Distribution StatusIn Commercial Distribution
Brand NameEarplugs
Version Model NumberCP9086000
Company DUNS785952607
Company NameIntersurgical Incorporated
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816472023245 [Primary]
GS100816472023252 [Package]
Contains: 00816472023245
Package: [25 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 Date2023-06-28
Device Publish Date2023-06-20

Devices Manufactured by Intersurgical Incorporated

05030267166077 - VENTURI VALVE 24% OXYGEN, BLUE2024-04-12 VENTURI VALVE 24% OXYGEN, BLUE
05030267166145 - VENTURI VALVE 28% OXYGEN, WHITE2024-04-12 VENTURI VALVE 28% OXYGEN, WHITE
05030267166176 - VENTURI VALVE 35% OXYGEN, YELLOW2024-04-12 VENTURI VALVE 35% OXYGEN, YELLOW
05030267166206 - VENTURI VALVE 40% OXYGEN, RED2024-04-12 VENTURI VALVE 40% OXYGEN, RED
05030267166237 - VENTURI VALVE 60% OXYGEN, GREEN2024-04-12 VENTURI VALVE 60% OXYGEN, GREEN
05030267166268 - VENTURI VALVE 50% OXYGEN, PINK2024-04-12 VENTURI VALVE 50% OXYGEN, PINK
05030267166299 - VENTURI VALVE 31% OXYGEN, ORANGE2024-04-12 VENTURI VALVE 31% OXYGEN, ORANGE
05030267011674 - MONITORING LINE 1.8M, MALE - MALE LUER LOCK CONNECTORS2024-02-28 MONITORING LINE 1.8M, MALE - MALE LUER LOCK CONNECTORS

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