InHealth Technologies; Blom-Singer®

GUDID 00848253003139

ENT surgical procedure kit, non-medicated, single-use

Primary Device ID	00848253003139
NIH Device Record Key	d36cca3f-4382-42a6-9b20-0a860bd628ae
Commercial Distribution Status	In Commercial Distribution
Brand Name	InHealth Technologies; Blom-Singer®
Version Model Number	TP 2212-LEF
Company DUNS	120981337
Company Name	Freudenberg Medical, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00848253003139 [Primary]

MMO	Tray, Surgical, Ent

Steralize Prior To Use	false
Device Is Sterile	true

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