FDA.reportPublic FDA data

Spectros T-Stat

Primary DI
10851136007015
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6508514040info@spectros.com

Regulatory Flags#

DUNS number
929856680
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00851136007018Spectros T-StatCTH-060-SUR 1cm2016-10-17
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
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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