SUPERSOFT™ T-TUBE

Basic Information

• Brand Name: SUPERSOFT™ T-TUBE
• Primary DI: 00844505012621
• Version / Model: 510-361
• Company Name: Grace Medical, Inc.
• Labeler DUNS: 030849173
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-11
• Public Version: 2
• Public Version Date: 2021-01-22
• Public Version Status: Update
• Public Device Record Key: bc2e4fa1-e552-4b0e-8027-4f92a45d064a

Device Description

SUPERSOFT™ T-TUBE 1.14MM ID X 8MM LENGTH SILICONE 5 PACK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ETD	TUBE, TYMPANOSTOMY	Ear, Nose, Throat	874.3880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33794	Tympanostomy tube	A small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10844505012628	GS1		5	In Commercial Distribution
Primary	00844505012621	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K830228	000