Pope

GUDID 20763000039206

VENT TUBE 1040014 10PK POPE GROMMET 1.14

MEDTRONIC XOMED, INC.

Tympanostomy tube Tympanostomy tube Tympanostomy tube
Primary Device ID20763000039206
NIH Device Record Key11da067f-b748-4ab1-96b2-d3922a12a4af
Commercial Distribution StatusIn Commercial Distribution
Brand NamePope
Version Model Number1040014
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 Diameter1.14 Millimeter
Lumen/Inner Diameter1.14 Millimeter
Lumen/Inner Diameter1.14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000039202 [Primary]
GS100763000039202 [Primary]
GS100763000039202 [Primary]
GS120763000039206 [Package]
Contains: 00763000039202
Package: PK [10 Units]
In Commercial Distribution
GS120763000039206 [Package]
Contains: 00763000039202
Package: PK [10 Units]
In Commercial Distribution
GS120763000039206 [Package]
Contains: 00763000039202
Package: PK [10 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 [Pope]

20681490032531VENT TUBE 1066039 10PK POPE TAIL PR 1.14
20681490032517VENT TUBE 1066036 10PK POPE TYPE PR 1.14
20681490031916VENT TUBE 1056039 5PK POPE W/TAIL 1.14
20681490031893VENT TUBE 1056036 5PK POPE HC-FLEX 1.14
20681490031114VENT TUBE 1040014 10PK POPE GROMMET 1.14
20681490029371VENT TUBE 1025007 50PK POPE GROMMET FLPL
20681490029340VENT TUBE 1025004 5PK POPE BEV GROM FLPL
20763000039206VENT TUBE 1040014 10PK POPE GROMMET 1.14

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