Soileau Tytan®

GUDID 20763000039442

VENT TUBE 1056111 5PK SOILEAU TYTAN

MEDTRONIC XOMED, INC.

Tympanostomy tube Tympanostomy tube Tympanostomy tube
Primary Device ID20763000039442
NIH Device Record Key70e150e3-241a-4a81-9515-b9ef65bec96a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoileau Tytan®
Version Model Number1056111
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Lumen/Inner Diameter1.27 Millimeter
Lumen/Inner Diameter1.27 Millimeter
Lumen/Inner Diameter1.27 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000039448 [Primary]
GS100763000039448 [Primary]
GS100763000039448 [Primary]
GS120763000039442 [Package]
Contains: 00763000039448
Package: PK [5 Units]
In Commercial Distribution
GS120763000039442 [Package]
Contains: 00763000039448
Package: PK [5 Units]
In Commercial Distribution
GS120763000039442 [Package]
Contains: 00763000039448
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETDTUBE, TYMPANOSTOMY
ETDTUBE, TYMPANOSTOMY
ETDTUBE, TYMPANOSTOMY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [Soileau Tytan®]

20681490033040VENT TUBE 1076111 50PK SOILEAU TYTAN
20681490032586VENT TUBE 1066111 10PK PAIR SOILEAU TYT
20681490032012VENT TUBE 1056111 5PK SOILEAU TYTAN
20763000039725VENT TUBE 1066111 10PK PAIR SOILEAU TYT
20763000039442VENT TUBE 1056111 5PK SOILEAU TYTAN

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