DEVICE: SWIK (00860349001713)

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Device Record History
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Device Identifier (DI) Information
SWIK
SWK-200
In Commercial Distribution

Saliva Management Systems, Inc.
00860349001713
GS1

1
119148960 *Terms of Use
Non-Invasive oral secretion management tool.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
Yes
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?
37434 Dental suction system cannula, single-use
A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DYN Mouthpiece, Saliva Ejector
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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
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
6bc5ea46-e959-4a2b-b628-31c01affd580
May 13, 2024
1
May 05, 2024
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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
10860349001703 10 00860349001713 2024-05-05 Not in Commercial Distribution 2mil Poly Bag
30860349001714 25 00860349001713 2024-05-05 Not in Commercial Distribution 2mil Poly Bag
20860349001717 50 00860349001713 2024-05-05 Not in Commercial Distribution 2mil Poly Bag
10860349001710 100 00860349001713 2024-05-05 Not in Commercial Distribution 2mil Poly Bag
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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

[?]
No Customer Contact currently defined
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