Paparella

GUDID 20763000039190

VENT TUBE 1040006 10PK PAPA PR 1.14 SIL

MEDTRONIC XOMED, INC.

Tympanostomy tube Tympanostomy tube Tympanostomy tube
Primary Device ID20763000039190
NIH Device Record Key0fb69cc0-28fb-4194-84fd-d4f401aba9bb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePaparella
Version Model Number1040006
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
GS100763000039196 [Primary]
GS100763000039196 [Primary]
GS100763000039196 [Primary]
GS120763000039190 [Package]
Contains: 00763000039196
Package: PK [10 Units]
In Commercial Distribution
GS120763000039190 [Package]
Contains: 00763000039196
Package: PK [10 Units]
In Commercial Distribution
GS120763000039190 [Package]
Contains: 00763000039196
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 [Paparella]

20613994146124VENT TUBE 1082203 50PK PAPA TYPE 1.14
20613994146117VENT TUBE 1082202 10PK PAPA TYPE PR 1.14
20613994146100VENT TUBE 1082201 5PK PAPA TYPE 1.14
20681490825478VENT TUBE MV1027 10PK PAPARELLA 1.14MM
20681490306816VENT TUBE MV1076 10PK PAPA TYPE 2 1.52MM
20681490063306VENT TUBE 25442 10PK PAPA PAIR .040 SIL
20681490063290VENT TUBE 25441 MICROGEL 5PK PAPA 1.02
20681490062712VENT TUBE 24461 5PK PAPA FIRM SIL 1.27MM
20681490062705VENT TUBE 24452 10PK PAPA PAIR 1.02 SIL
20681490062699VENT TUBE 24451 5PK PAPA FIRM SIL 1.02MM
20681490062682VENT TUBE 24442 10PK PAPA PAIR 1.02 SIL
20681490062675VENT TUBE 24441 5PK PAPA FIRM SIL 1.02MM
20681490041151VENT TUBE 14521 5PK PAPA W/TAB 1.02 FLPL
20681490032432VENT TUBE 1066005 10PK PAPA PAIRS 1.02MM
20681490031770VENT TUBE 1056005 5PK PAPA W/TAB 1.02
20681490031350VENT TUBE 1046001 10PK PAPA 1 PAIRS
20681490031138VENT TUBE 1040019 100PK PAPA PAIR 1.14
20681490031077VENT TUBE 1040006 10PK PAPA PR 1.14 SIL
20681490029579VENT TUBE 1026045 ACTIVENT 5PK PAPA 2
20681490029487VENT TUBE 1026001 ACTIVENT 5PK PAPA 1
20681490029401VENT TUBE 1025045 5PK PAPA NTCH/TAB 1.52
20681490029395VENT TUBE 1025040 5PK PAPA W/NOTCH 1.52
20681490029357VENT TUBE 1025005 5PK PAPA W/NOTCH 1.14
20681490029326VENT TUBE 1025002 50PK PAPA NOTCH/TAB
20681490029319VENT TUBE 1025001 5PK PAPA NOTCH/TAB SIL
20681490028299VENT TUBE 1012010 5PK PAPARELLA W/MEMBR
20763000039961VENT TUBE 14521 5PK PAPA W/TAB 1.02 FLPL
20763000040387VENT TUBE 24452 10PK PAPA PAIR 1.02 SIL
20763000040370VENT TUBE 24451 5PK PAPA FIRM SIL 1.02MM
20763000040363VENT TUBE 24442 10PK PAPA PAIR 1.02 SIL
20763000040356VENT TUBE 24441 5PK PAPA FIRM SIL 1.02MM
20763000039213VENT TUBE 1040019 100PK PAPA PAIR 1.14
20763000039190VENT TUBE 1040006 10PK PAPA PR 1.14 SIL
20763000038759VENT TUBE 1025045 5PK PAPA NTCH/TAB 1.52
20763000038728VENT TUBE 1025005 5PK PAPA W/NOTCH 1.14
20763000038704VENT TUBE 1025002 50PK PAPA NOTCH/TAB
20763000038698VENT TUBE 1025001 5PK PAPA NOTCH/TAB SIL

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