FDA.report

TRACOE larynx

Primary DI
04035324045310
Brand
TRACOE larynx
Company
Tracoe medical GmbH
Model
REF 613-07
Catalog number
REF 613-07
Device description
TRACOE stoma button Long
Published
2016-01-14
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
false

Related Records

Contact Domains

Product Codes

CodeName
KACTUBE, LARYNGECTOMY

Product Code Classifications

CodeDeviceSpecialtyClass
KACTube, LaryngectomyEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04035324045310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04035324045310040353240453104035324045310

GMDN Terms

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

TypeValueUnit
Lumen/Inner Diameter7Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from rain. Keep away from sunlight. Do not resterilize.

Sterilization Methods

Method

Contacts

PhoneEmail
+49613691690info@tracoe.com

Regulatory Flags

DUNS number
319414785
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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
04035324000210TRACOE® comfortREF 101-042017-07-01
04035324001415TRACOE® comfortREF 102-03D2017-07-01
04035324001811TRACOE® comfortREF 102-04D2017-07-01

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