Silverstein

GUDID 20763000038995

VENT TUBE 1028065 5PK SPAT 1.14X12MM SIL

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 Tympanostomy tube Tympanostomy tube
Primary Device ID20763000038995
NIH Device Record Key35617ba0-dc59-4b2f-884b-15a5831e8c95
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilverstein
Version Model Number1028065
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
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
Lumen/Inner Diameter1.14 Millimeter
Length12 Millimeter
Lumen/Inner Diameter1.14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000038991 [Primary]
GS120763000038995 [Package]
Contains: 00763000038991
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETDTUBE, TYMPANOSTOMY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-01
Device Publish Date2020-04-23

On-Brand Devices [Silverstein]

20681490040819PACKING 1428010 6PK REG STRIPS POLYEST
20681490040802PACKING 1428005 6PK LONG STRIPS POLYEST
20681490040765PACKING 1425020 6PK REG STRIPS FLPL
20681490040758PACKING 1425015 6PK LONG STRIPS FLPL
00681490033428PROSTHESIS 1112120 H/A INCUS-STAPES CONN
20681490030049VENT TUBE 1028070 5PK SPAT 1.14X7MM SIL
20681490030032VENT TUBE 1028065 5PK SPAT 1.14X12MM SIL
20763000038995VENT TUBE 1028065 5PK SPAT 1.14X12MM SIL
00763000034757PROSTHESIS 1112120 H/A INCUS-STAPES CONN

Trademark Results [Silverstein]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SILVERSTEIN
SILVERSTEIN
78368041 not registered Dead/Abandoned
Exploring Music, Inc.
2004-02-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.