DEVICE: Span-America (H933SP265000)

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Device Record History
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Device Identifier (DI) Information
Span-America
SPAN AIDS
In Commercial Distribution
SP265-000
SPAN-AMERICA MEDICAL SYSTEMS, INC.
H933SP265000
HIBCC

1
073704413 *Terms of Use
O.R. WEDGE 18 X 8 X 8 8/CS (P01420)
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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?
66292 Gnathodynamometer
An electrically-powered instrument intended to measure the maximal bite force produced when closing the jaw/mouth. It consists of a mouthpiece on which the patient bites, which transmits the measured force to sensors within a connected control unit for display on a digital user interface. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IKY Mattress, Flotation Therapy, Non-Powered
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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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
46adf303-ce48-4814-a9ab-4dfb687767b2
December 14, 2022
1
December 06, 2022
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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
No Package DIs found
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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
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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