TULA

Primary DI
20885556817685
Brand
TULA
Company
Smith & Nephew, Inc.
Model
72290091
Catalog number
72290091
Device description
TULA EARPLUG 10-PACK- SIZE 1 (NST007070)
Published
2024-04-23
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
P190016007
P190016008

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190016007Tula® SystemTusker Medical, Inc.2019-11-25QJA
P190016008Tula® SystemTusker Medical, Inc.2019-11-25QJA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885556817685PrimaryGS10
00885556817681Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088555681768520885556817685
00885556817681008855568176818855568176810885556817681

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
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556819845Uni-CP Compression Plate286322ND286322ND2023-11-07
00885556819852Uni-CP Compression Plate286324ND286324ND2023-11-07
00885556819869Uni-CP Compression Plate286326ND286326ND2023-11-07
00885556819876Uni-CP Compression Plate286328ND286328ND2023-11-07
00885556819883Uni-CP Compression Plate286330ND286330ND2023-11-07
00885556819890Uni-CP Compression Plate286332ND286332ND2023-11-07
00885556819906Uni-CP Compression Plate286334ND286334ND2023-11-07
00885556819357General Instruments219865ND219865ND2023-10-27
00885556846599Total Wrist Fusion186200ND186200ND2023-10-27
00885556910245UNI-CP Compression Plate186300ND186300ND2023-10-27
00885556819722Total Wrist Fusion286220ND286220ND2023-10-26
00885556819746Total Wrist Fusion286222ND286222ND2023-10-26
00885556819760Total Wrist Fusion286224ND286224ND2023-10-26
00885556819807UNI-CP Compression Plate286314ND286314ND2023-10-26
00885556819814UNI-CP Compression Plate286316ND286316ND2023-10-26
00885556819821UNI-CP Compression Plate286318ND286318ND2023-10-26
00885556819838UNI-CP Compression Plate286320ND286320ND2023-10-26
00885556847329UNI-CP Compression Plate219535ND219535ND2023-10-26
00885556819623Total Wrist Fusion286210ND286210ND2023-10-25
00885556819647SURFIXTotal Wrist Fusion286212ND286212ND2023-10-25

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
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
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