AccessGUDID - DEVICE: EXMOOR (05060180255848)

GUDID

Device Identifier (DI) Information

Brand Name: EXMOOR
Version or Model: E.1006
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: E.1006
Company Name: EXMOOR PLASTICS LIMITED

Primary DI Number: 05060180255848
Issuing Agency: GS1
Commercial Distribution End Date: August 27, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 298725490 *Terms of Use

Device Description: Aural Grommet

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ETD	Tube, Tympanostomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K911580	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
Special Storage Condition, Specify: Keep out of direct sunlight.
Storage Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Special Storage Condition, Specify: Store in a dry environment. Avoid extremes of temperature and humidity.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: daddf905-213f-4ead-9c44-f972bdc2e5d7
Public Version Date: January 22, 2021
Public Version Number: 3
DI Record Publish Date: September 20, 2018