DEVICE: EXMOOR (05060180259228)

Device Identifier (DI) Information

EXMOOR
D1.
In Commercial Distribution
D1.
EXMOOR PLASTICS LIMITED
05060180259228
GS1

1
298725490 *Terms of Use
Silicone Tooth Protector
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38621 Mouthguard, reusable
A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during endoscopic diagnostic procedures, contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MNK Endoscopic Bite Block
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

a03ad6ab-0f26-4204-9bf8-79bf76140868
December 21, 2020
2
September 20, 2018
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05060180255213 20 05060180259228 In Commercial Distribution a box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+441823351040
sales@exmoorltd.com
CLOSE