Microgel®

GUDID 20763000040554

VENT TUBE 25502 10PK ARMSTRONG PAIR 1.14

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 ID20763000040554
NIH Device Record Key0d13ffa0-30aa-4d8f-ad6d-358cc9c5776c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicrogel®
Version Model Number25502
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
Lumen/Inner Diameter1.14 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Lumen/Inner Diameter1.14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000040550 [Primary]
GS100763000040550 [Primary]
GS100763000040550 [Primary]
GS100763000040550 [Primary]
GS100763000040550 [Primary]
GS100763000040550 [Primary]
GS100763000040550 [Primary]
GS100763000040550 [Primary]
GS100763000040550 [Primary]
GS100763000040550 [Primary]
GS100763000040550 [Primary]
GS100763000040550 [Primary]
GS100763000040550 [Primary]
GS100763000040550 [Primary]
GS120763000040554 [Package]
Contains: 00763000040550
Package: PK [10 Units]
In Commercial Distribution
GS120763000040554 [Package]
Contains: 00763000040550
Package: PK [10 Units]
In Commercial Distribution
GS120763000040554 [Package]
Contains: 00763000040550
Package: PK [10 Units]
In Commercial Distribution
GS120763000040554 [Package]
Contains: 00763000040550
Package: PK [10 Units]
In Commercial Distribution
GS120763000040554 [Package]
Contains: 00763000040550
Package: PK [10 Units]
In Commercial Distribution
GS120763000040554 [Package]
Contains: 00763000040550
Package: PK [10 Units]
In Commercial Distribution
GS120763000040554 [Package]
Contains: 00763000040550
Package: PK [10 Units]
In Commercial Distribution
GS120763000040554 [Package]
Contains: 00763000040550
Package: PK [10 Units]
In Commercial Distribution
GS120763000040554 [Package]
Contains: 00763000040550
Package: PK [10 Units]
In Commercial Distribution
GS120763000040554 [Package]
Contains: 00763000040550
Package: PK [10 Units]
In Commercial Distribution
GS120763000040554 [Package]
Contains: 00763000040550
Package: PK [10 Units]
In Commercial Distribution
GS120763000040554 [Package]
Contains: 00763000040550
Package: PK [10 Units]
In Commercial Distribution
GS120763000040554 [Package]
Contains: 00763000040550
Package: PK [10 Units]
In Commercial Distribution
GS120763000040554 [Package]
Contains: 00763000040550
Package: PK [10 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

On-Brand Devices [Microgel®]

20763000041315VENT TUBE 25443 50PK PAPA .040 SIL
20763000040554VENT TUBE 25502 10PK ARMSTRONG PAIR 1.14
20763000040547VENT TUBE 25501 MICROGEL 5PK ARMSTG 1.14
20763000040523VENT TUBE 25441 MICROGEL 5PK PAPA 1.02
20763000037516VENT TUBE 1084401 5PK GROMMET 1.27
20763000037509VENT TUBE 1083303 50PK SHEEHY TYPE 1.27
20763000037486VENT TUBE 1083301 5PK SHEEHY TYPE 1.27
20763000037479VENT TUBE 1082203 50PK PAPA TYPE 1.14
20763000037462VENT TUBE 1082202 10PK PAPA TYPE PR 1.14
20763000037455VENT TUBE 1082201 5PK PAPA TYPE 1.14
20763000037431VENT TUBE 1081101 5PK ARMS MOD GROM 1.14

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