FDA.reportPublic FDA data

Spectros T-Stat

Primary DI
00851136007018
Brand
Spectros T-Stat
Company
SPECTROS CORPORATION
Model
CTH-060-SUR 1cm
Device description
1 cm diameter surface sensor for use with the T-Stat Monitor to measure ischemia.
Published
2016-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUDOximeter, Tissue Saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUDOximeter, Tissue SaturationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081233000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081233000T-STAT 303 ISCHEMIA MONITORING SYSTEMSpectros Corporation2008-07-28MUD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851136007015PackageGS15In Commercial Distribution
00851136007018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085113600701510851136007015
00851136007018008511360070188511360070180851136007018

GMDN Terms#

Term, Definition table
TermDefinition
Tissue saturation oximeter sensor, single-useA 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.

Contacts#

Phone, Email table
PhoneEmail
6508514040info@spectros.com

Regulatory Flags#

DUNS number
929856680
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851136007063Spectros T-StatT-Stat 2.0T-Stat 2.02019-10-21
00851136007001Spectros T-StatCTH-060-SUR 2.5cm2016-10-03
00851136007032Spectros T-StatCHT-060-REC 5mm2016-10-17
00851136007049Spectros T-StatCTH-060-ORA M2016-10-17
10851136007008Spectros T-StatCTH-060-SUR 2.5cm2016-10-03
10851136007015Spectros T-StatCTH-060-SUR 1cm2016-10-17
00851136007025Spectros T-StatCTH-060-END 2.3M2016-10-17
10851136007039Spectros T-StatCHT-060-REC 5mm2016-10-17
10851136007046Spectros T-StatCTH-060-ORA M2016-10-17
00851136007056Spectros T-StatT-Stat 303T-Stat 3032016-10-03

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Primary DI, Brand, Company table
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