TULA

Primary DI
00840128600016
Brand
TULA
Company
Smith & Nephew, Inc.
Model
TULAKIT1L
Catalog number
TULAKIT1L
Device description
TULA KIT - UNILATERAL - LONG EARSET
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
P190016002

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190016000Tula® SystemTusker Medical, Inc.2019-11-25QJA
P190016002Tula® SystemTusker Medical, Inc.2019-11-25QJA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840128600016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840128600016008401286000168401286000160840128600016

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.

Sterilization Methods#

Method table
Method

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
00885556919781Real IntelligenceROB30007ROB300072026-10-13
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30
00885556236949STRUCSURE7178057178052016-04-08
00885556236994STRUCSURE7178087178082016-04-08
00885556237045STRUCSURE7178167178162016-04-08
00885556838211Total Foot System 2280500728050072023-04-18
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15

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
00840128600115TULASmith & Nephew, Inc.QJA2020-03-25
00840128600122TULASmith & Nephew, Inc.QJA2020-03-25
00840128600207TULASmith & 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