DEVICE: Thermasplint (00645724003663)
Device Identifier (DI) Information
Thermasplint
SP-1501B-CORD7
In Commercial Distribution
SP1501BCORD7
Whitehall Manufacturing Co
SP-1501B-CORD7
In Commercial Distribution
SP1501BCORD7
Whitehall Manufacturing Co
FORMA SPLINT W/ 220V INDIA/S.A. CORD(LG)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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17526 | Thermoplastic-moulding water bath |
A mains electricity (AC-powered) water bath specifically designed for the warming/heating of mouldable plastic materials (thermoplastics) used to create body positioning and body fixation devices, splints, and orthotic devices. It will typically consist of a large water holder (pan) that is temperature-regulated from, e.g., room temperature to 100? Celsius, temperature controls, thermometer/thermostats, timer. Sheets or pre-cut pieces of thermoplastic materials are placed into the water with the temperature set according to the material specifications so that these become soft enough to mould to the required shape.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IRQ | Unit, Heating, Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0a75d1c8-97a2-4d52-96fa-c36f014bf0e8
March 11, 2019
1
February 12, 2019
March 11, 2019
1
February 12, 2019
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
[?]
(800) 782-7706
info@whitehallmfg.com
info@whitehallmfg.com