TULA EP5O

GUDID 20840128600119

TULA EARPLUG 10-PACK-SIZE 5

Smith & Nephew, Inc.

Drug-delivery iontophoresis system, single-use

• Primary Device ID: 20840128600119
• NIH Device Record Key: 35c0fafb-3963-4762-917a-872b3d113535
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TULA
• Version Model Number: EP5O
• Catalog Number: EP5O
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840128600115 [Primary]
GS1	20840128600119 [Package]; Contains: 00840128600115; Package: BX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190016

FDA Product Code

• QJA: Tympanostomy tube delivery product with drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-21
• Device Publish Date: 2020-03-25

On-Brand Devices [TULA]

• 00840128600009: TULAKIT - UNILATERAL
• 00840128600160: TULA EARPLUG SIZERS
• 20840128600201: TULA EARSET SPARE - LONG
• 00840128600153: TULA IONTOPHORESIS PATCH
• 00840128600146: TULA CONTROL UNIT SPARE
• 00840128600139: TYMBION AND SYRINGE PACK
• 20840128600126: TULA EARPLUG 10-PACK-SIZE6
• 20840128600119: TULA EARPLUG 10-PACK-SIZE 5
• 20840128600102: TULA EARPLUG 10-PACK - SIZE 4
• 20840128600096: TULA EARPLUG 10-PACK-SIZE 3
• 20840128600089: TULA EARPLUG 10-PACK -SIZE 2
• 20840128600072: TULA EARPLUG 10-PACK-SIZE 1
• 20840128600058: TULA EARSET SPARE - REGULAR
• 00840128600047: TULA TDS 1.14 GROMMET
• 00840128600030: TULA KIT - BILATERAL - LONG EARSET
• 00840128600023: TULA KIT- BILATERAL
• 00840128600016: TULA KIT - UNILATERAL - LONG EARSET
• 20885556817739: TULA EARPLUG 10-PACK- SIZE 6 (NST007075)
• 20885556817722: TULA EARPLUG 10-PACK- SIZE 5 (NST007074)
• 20885556817715: TULA EARPLUG 10-PACK- SIZE 4 (NST007073)
• 20885556817708: TULA EARPLUG 10-PACK- SIZE 3 (NST007072)
• 20885556817692: TULA EARPLUG 10-PACK- SIZE 2 (NST007071)
• 20885556817685: TULA EARPLUG 10-PACK- SIZE 1
• 00885556817797: TULA IONTOPHORESIS PATCH
• 00885556817780: TULA CONTROL UNIT SPARE
• 00885556817773: TULA EARPLUG SIZERS
• 00885556817766: TYMBION AND SYRINGE PACK (STR007013)
• 00885556817759: TULA EARSET SPARE
• 00885556817742: TULA TDS 1.14 GROMMET
• 00885556817674: TULA KIT- BILATERAL (NST007069)
• 00885556817667: TULA KIT- UNILATERAL (NST007068)