DEVICE: EXMOOR (05060180257583)

Device Identifier (DI) Information

EXMOOR
N14
In Commercial Distribution
N14
EXMOOR PLASTICS LIMITED
05060180257583
GS1

1
298725490 *Terms of Use
Nasal Splint
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
31919 Intranasal splint, non-biodegradable
A non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LYA Splint, Intranasal Septal
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FDA Premarket Submission

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

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

[?]
Size Type Text
No Device Sizes
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Device Record Status

5be75609-e87d-4f53-b636-76ae11dee670
December 21, 2020
3
September 14, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05060180251222 20 05060180257583 In Commercial Distribution a box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+441823351040
sales@exmoorltd.com
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