T-Tube® Microgel®

GUDID 20763000037530

VENT TUBE 1087701 5PK GOODE T 1.14X12MM

MEDTRONIC XOMED, INC.

Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube
Primary Device ID20763000037530
NIH Device Record Keyc5f46933-8550-4efb-a128-f5a42f5f52f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameT-Tube® Microgel®
Version Model Number1087701
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
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
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
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000037536 [Primary]
GS100763000037536 [Primary]
GS100763000037536 [Primary]
GS100763000037536 [Primary]
GS100763000037536 [Primary]
GS100763000037536 [Primary]
GS100763000037536 [Primary]
GS100763000037536 [Primary]
GS100763000037536 [Primary]
GS100763000037536 [Primary]
GS100763000037536 [Primary]
GS100763000037536 [Primary]
GS100763000037536 [Primary]
GS100763000037536 [Primary]
GS120763000037530 [Package]
Contains: 00763000037536
Package: PK [5 Units]
In Commercial Distribution
GS120763000037530 [Package]
Contains: 00763000037536
Package: PK [5 Units]
In Commercial Distribution
GS120763000037530 [Package]
Contains: 00763000037536
Package: PK [5 Units]
In Commercial Distribution
GS120763000037530 [Package]
Contains: 00763000037536
Package: PK [5 Units]
In Commercial Distribution
GS120763000037530 [Package]
Contains: 00763000037536
Package: PK [5 Units]
In Commercial Distribution
GS120763000037530 [Package]
Contains: 00763000037536
Package: PK [5 Units]
In Commercial Distribution
GS120763000037530 [Package]
Contains: 00763000037536
Package: PK [5 Units]
In Commercial Distribution
GS120763000037530 [Package]
Contains: 00763000037536
Package: PK [5 Units]
In Commercial Distribution
GS120763000037530 [Package]
Contains: 00763000037536
Package: PK [5 Units]
In Commercial Distribution
GS120763000037530 [Package]
Contains: 00763000037536
Package: PK [5 Units]
In Commercial Distribution
GS120763000037530 [Package]
Contains: 00763000037536
Package: PK [5 Units]
In Commercial Distribution
GS120763000037530 [Package]
Contains: 00763000037536
Package: PK [5 Units]
In Commercial Distribution
GS120763000037530 [Package]
Contains: 00763000037536
Package: PK [5 Units]
In Commercial Distribution
GS120763000037530 [Package]
Contains: 00763000037536
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETDTUBE, TYMPANOSTOMY
ETDTUBE, TYMPANOSTOMY
ETDTUBE, TYMPANOSTOMY
ETDTUBE, TYMPANOSTOMY
ETDTUBE, TYMPANOSTOMY
ETDTUBE, TYMPANOSTOMY
ETDTUBE, TYMPANOSTOMY
ETDTUBE, TYMPANOSTOMY
ETDTUBE, TYMPANOSTOMY
ETDTUBE, TYMPANOSTOMY
ETDTUBE, TYMPANOSTOMY
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 Date2020-09-14
Device Publish Date2020-09-06

Devices Manufactured by MEDTRONIC XOMED, INC.

00763000299286 - Straightshot2020-09-15 INSTRUMENT TRAY 1899076 M5
20763000037431 - Microgel®2020-09-14 VENT TUBE 1081101 5PK ARMS MOD GROM 1.14
20763000037455 - Microgel®2020-09-14 VENT TUBE 1082201 5PK PAPA TYPE 1.14
20763000037462 - Microgel®2020-09-14 VENT TUBE 1082202 10PK PAPA TYPE PR 1.14
20763000037479 - Microgel®2020-09-14 VENT TUBE 1082203 50PK PAPA TYPE 1.14
20763000037486 - Microgel®2020-09-14 VENT TUBE 1083301 5PK SHEEHY TYPE 1.27
20763000037493 - Microgel™2020-09-14 VENT TUBE 1083302 10PK SHEEHY PAIR 1.27
20763000037509 - Microgel®2020-09-14 VENT TUBE 1083303 50PK SHEEHY TYPE 1.27

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.