TULA

Primary DI
00840128600115
Brand
TULA
Company
Smith & Nephew, Inc.
Model
EP5O
Catalog number
EP5O
Device description
TULA EARPLUG 10-PACK-SIZE 5
Published
2020-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QJATympanostomy tube delivery product with drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJATympanostomy Tube Delivery Product With DrugUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190016000Tula® SystemTusker Medical, Inc.2019-11-25QJA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20840128600119PackageGS110In Commercial Distribution
00840128600115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084012860011920840128600119
00840128600115008401286001158401286001150840128600115

GMDN Terms#

Term, Definition table
TermDefinition
Drug-delivery iontophoresis system, single-useAn assembly of portable devices that may be used as an alternative to injections to transport ionic-solution medication through the movement of ions resulting from an applied electric field, to locally administer the medication transcutaneously. It typically consists of a disposable, battery-powered, current generator that supplies a constant direct current [e.g., 0.5 to 4 milliampere (mA)], a delivery electrode which typically contains a small reservoir of buffering agent and the medication (e.g., a corticosteroid or anaesthetic), a return electrode, and connecting lead wires. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556817667TULASmith & Nephew, Inc.QJA2024-04-29
00885556817674TULASmith & Nephew, Inc.QJA2024-04-23
00885556817742TULASmith & Nephew, Inc.QJA2024-04-23
00885556817759TULASmith & Nephew, Inc.QJA2024-04-23
00885556817766TULASmith & Nephew, Inc.QJA2024-04-23
00885556817773TULASmith & Nephew, Inc.QJA2024-04-23
00885556817780TULASmith & Nephew, Inc.QJA2024-04-23
00885556817797TULASmith & Nephew, Inc.QJA2024-04-23
20885556817685TULASmith & Nephew, Inc.QJA2024-04-23
20885556817692TULASmith & Nephew, Inc.QJA2024-04-23
20885556817708TULASmith & Nephew, Inc.QJA2024-04-23
20885556817715TULASmith & Nephew, Inc.QJA2024-04-23
20885556817722TULASmith & Nephew, Inc.QJA2024-04-23
20885556817739TULASmith & Nephew, Inc.QJA2024-04-23
00840128600160TULASmith & Nephew, Inc.QJA2020-03-27
00840128600054TULASmith & Nephew, Inc.QJA2020-03-25
00840128600078TULASmith & Nephew, Inc.QJA2020-03-25
00840128600085TULASmith & Nephew, Inc.QJA2020-03-25
00840128600092TULASmith & Nephew, Inc.QJA2020-03-25
00840128600108TULASmith & Nephew, Inc.QJA2020-03-25
00840128600122TULASmith & Nephew, Inc.QJA2020-03-25
00840128600207TULASmith & Nephew, Inc.QJA2020-03-25
00840128600016TULASmith & Nephew, Inc.QJA2020-03-25
00840128600023TULASmith & Nephew, Inc.QJA2020-03-25
00840128600030TULASmith & Nephew, Inc.QJA2020-03-25
00840128600047TULASmith & Nephew, Inc.QJA2020-03-25
20840128600058TULASmith & Nephew, Inc.QJA2020-03-25
20840128600072TULASmith & Nephew, Inc.QJA2020-03-25
20840128600089TULASmith & Nephew, Inc.QJA2020-03-25
20840128600096TULASmith & Nephew, Inc.QJA2020-03-25