TULA EP4Y

GUDID 20840128600102

TULA EARPLUG 10-PACK - SIZE 4

Smith & Nephew, Inc.

Drug-delivery iontophoresis system, single-use Drug-delivery iontophoresis system, single-use Drug-delivery iontophoresis system, single-use
Primary Device ID20840128600102
NIH Device Record Key03da9e8e-aa37-42d2-b4af-d59263b7aead
Commercial Distribution StatusIn Commercial Distribution
Brand NameTULA
Version Model NumberEP4Y
Catalog NumberEP4Y
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100840128600108 [Primary]
GS100840128600108 [Primary]
GS100840128600108 [Primary]
GS120840128600102 [Package]
Contains: 00840128600108
Package: BX [10 Units]
In Commercial Distribution
GS120840128600102 [Package]
Contains: 00840128600108
Package: BX [10 Units]
In Commercial Distribution
GS120840128600102 [Package]
Contains: 00840128600108
Package: BX [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QJATympanostomy tube delivery product with drug
QJATympanostomy tube delivery product with drug
QJATympanostomy tube delivery product with drug

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-21
Device Publish Date2020-03-25

On-Brand Devices [TULA]

00840128600009TULAKIT - UNILATERAL
00840128600160TULA EARPLUG SIZERS
20840128600201TULA EARSET SPARE - LONG
00840128600153TULA IONTOPHORESIS PATCH
00840128600146TULA CONTROL UNIT SPARE
00840128600139TYMBION AND SYRINGE PACK
20840128600126TULA EARPLUG 10-PACK-SIZE6
20840128600119TULA EARPLUG 10-PACK-SIZE 5
20840128600102TULA EARPLUG 10-PACK - SIZE 4
20840128600096TULA EARPLUG 10-PACK-SIZE 3
20840128600089TULA EARPLUG 10-PACK -SIZE 2
20840128600072TULA EARPLUG 10-PACK-SIZE 1
20840128600058TULA EARSET SPARE - REGULAR
00840128600047TULA TDS 1.14 GROMMET
00840128600030TULA KIT - BILATERAL - LONG EARSET
00840128600023TULA KIT- BILATERAL
00840128600016TULA KIT - UNILATERAL - LONG EARSET

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