DEVICE: PAD SET WILSON FRAME TEMPUR PEDIC (00842430102042)
Device Identifier (DI) Information
PAD SET WILSON FRAME TEMPUR PEDIC
5319-37
In Commercial Distribution
5319-37
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5319-37
In Commercial Distribution
5319-37
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Pad set includes one each left and right pads. Designed for use with the 5319G or 5321G Wilson Plus™ Radiolucent Frames. Made with Tempur-Pedic® Medical materials.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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? |
---|---|---|---|---|
35184 | Operating table mattress, basic |
A foam-filled cushion designed as a component of an operating table to serve as the surface upon which the patient is placed. It is typically filled with high-density polyurethane or a memory foam, and may be an integral part of the table (i.e., removable only with tools) or loosely fitted to the table top (e.g., by way of press studs, Velcro strips, or eyeholes and pegs) and is removable for cleaning. The device is firm, waterproof, and washable using strong disinfectants. It is available as one full-length piece or in sections. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JEA | Table, Surgical With Orthopedic Accessories, Ac-Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 0 and 38 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9fdcc116-a234-4a5f-aa70-d90a40ca4373
September 19, 2023
5
May 01, 2017
September 19, 2023
5
May 01, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-777-4674
custserv@mizuhosi.com
custserv@mizuhosi.com