AccessGUDID - DEVICE: NA (00385640002417)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: VT-5000-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SUMMIT MEDICAL, INC.

Primary DI Number: 00385640002417
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 965484699 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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 grommet, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleous clip tube, attaches to the malleolus. Disposable devices associated with implantation may be included, which may be used to implant bilateral tubes.

GMDN Preferred Term Name

GMDN Definition

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 grommet, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleous clip tube, attaches to the malleolus. Disposable devices associated with implantation may be included, which may be used to implant bilateral tubes.

FDA Product Code

[?]

Product Code	Product Code Name
ETD	Tube, Tympanostomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K830228	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 431e48e9-60ce-4a8e-9401-56850ce2ce4b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016