InHealth Technologies; Blom-Singer®

GUDID 00848253002385

Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 8mm length

Freudenberg Medical, LLC

ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use ENT surgical procedure kit, non-medicated, single-use
Primary Device ID00848253002385
NIH Device Record Keya7241eba-4d8f-41b5-bc96-12c8c2689de0
Commercial Distribution StatusIn Commercial Distribution
Brand NameInHealth Technologies; Blom-Singer®
Version Model NumberTP 2008
Company DUNS120981337
Company NameFreudenberg Medical, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com
Phone800-477-5969
Emailinfo@inhealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848253002385 [Primary]

FDA Product Code

MMOTray, Surgical, Ent

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-13
Device Publish Date2023-11-03

On-Brand Devices [InHealth Technologies; Blom-Singer®]

00848253003139Blom-Singer® FirstFit Surgical Kit with 22.5Fr Voice Prosthesis, 12mm length
00848253003122Blom-Singer® FirstFit Surgical Kit with 22.5Fr Voice Prosthesis, 10mm length
00848253003115Blom-Singer® FirstFit Surgical Kit with 22.5Fr Voice Prosthesis, 8mm length
00848253003092Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 14mm length
00848253002606Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 12mm length
00848253002408Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 10mm length
00848253002385Blom-Singer® FirstFit Surgical Kit with 20Fr Classic Indwelling Voice Prosthesis, 8mm length
00848253002378Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 14mm length
00848253002361Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 12mm length
00848253002354Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 10mm length
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