DEVICE: Spectros T-Stat (00851136007018)

Device Identifier (DI) Information

Spectros T-Stat
CTH-060-SUR 1cm
In Commercial Distribution

SPECTROS CORPORATION
00851136007018
GS1

1
929856680 *Terms of Use
1 cm diameter surface sensor for use with the T-Stat Monitor to measure ischemia.
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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?
46618 Tissue saturation oximeter sensor, single-use
A photoelectric device that is applied externally to a site on the body surface of a paediatric or adult patient for transcutaneous measurement the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. It is connected to a tissue saturation oximeter via a fibreoptic cable and will typically include a light shield to protect the measurements from ambient light. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MUD Oximeter, Tissue Saturation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K081233 000
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Sterilization

Yes
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

7ed9b1e3-a387-48de-9a3b-5d23c3255dbd
July 06, 2018
3
October 17, 2016
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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
10851136007015 5 00851136007018 In Commercial Distribution 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

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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

[?]
6508514040
info@spectros.com
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