FDA.reportPublic FDA data

TRACOE® larynx

Primary DI
04035324043910
Brand
TRACOE® larynx
Company
Tracoe medical GmbH
Model
REF 603-12
Device description
TRACOE grid button Long
Published
2016-01-14
Public version status
Update
Distribution status
Not 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
KACTUBE, LARYNGECTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KACTube, LaryngectomyEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035324043910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035324043910040353240439104035324043910

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostoma buttonA hollow device intended to be used routinely by a patient to prevent the narrowing of a tracheostoma during intermittent use of their tracheostomy or laryngectomy tube. It is a cylindrical synthetic polymer device designed for minimal intrusion beyond the tracheostomal orifice into which it is placed. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter12Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Products must be stored in cool and dry location. Temporary storage for less or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49613691690info@tracoe.com

Regulatory Flags#

DUNS number
319414785
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035324012176TRACOE® careREF 938-A2016-03-15
04035324012183TRACOE® careREF 938-B2016-03-15
04035324012190TRACOE® careREF 938-C2016-03-15
04035324012220TRACOE® careREF 940-A2016-03-15
04035324012237TRACOE® careREF 940-B2016-03-15
04035324012244TRACOE® careREF 940-C2016-03-15
04035324012251TRACOE® careREF 940-D2016-03-15
04035324014927TRACOE® careREF 903-H-P2016-03-15
04035324014934TRACOE® careREF 903-I-P2016-03-15
04035324014941TRACOE® careREF 903-J-P2016-03-15
04035324014989TRACOE® careREF 903-H2015-10-24
04035324014996TRACOE® careREF 903-I2016-03-15
04035324015009TRACOE® careREF 903-J2016-03-15
04035324046812TRACOE® careREF 903-A2015-10-24
04035324047116TRACOE® careREF 903-D2015-10-24
04035324059812TRACOE® careREF 9362016-03-15
04035324059911TRACOE® careREF 9352016-03-15
04035324000111TRACOE® comfortREF 101-032017-07-01
04035324001118TRACOE® comfortREF 101-132017-07-01
04035324001217TRACOE® comfortREF 101-142017-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904428747900OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747917OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747924OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747931OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747948OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747955OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747962OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747979OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747986OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428747993OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428748006OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428748013OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314533OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314519OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314496OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314465OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314441OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314427OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314403OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08906039314380OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-12
08904428750634OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750641OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750658OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750665OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750672OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750689OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750696OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08904428750702OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08906039311716OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10
08906039315202OSSEOUSEON MEDITECH PRIVATE LIMITEDKAC2024-06-10