DEVICE: Forsure (00815123012799)

Device Identifier (DI) Information

Forsure
11150050
In Commercial Distribution
11150050
FORSURE MEDICAL PRODUCTS LLC
00815123012799
GS1

1
033809722 *Terms of Use
A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
42424 Oropharyngeal airway, single-use
A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAE Airway, Oropharyngeal, Anesthesiology
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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
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: STORE IN CLEAN DRY CONDITIONS AWAY FROM HEAT AND LIGHT
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 50mm
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Device Record Status

857e8e82-ed19-449f-8bcb-f8fa44fb46db
March 29, 2018
2
February 13, 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
20815123012793 45 10815123012796 In Commercial Distribution MASTER CASE
10815123012796 10 00815123012799 In Commercial Distribution INNER BOX
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Secondary DI

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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
No
Yes
Yes CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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