AccessGUDID - DEVICE: TRACOE® larynx (04035324045518)

GUDID

Device Identifier (DI) Information

Brand Name: TRACOE® larynx
Version or Model: REF 613-09
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tracoe medical GmbH

Primary DI Number: 04035324045518
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 319414785 *Terms of Use

Device Description: TRACOE stoma button Long

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
14093	Tracheostoma button	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAC	TUBE, LARYNGECTOMY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Products 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.

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 9.0 Millimeter

Device Record Status

Public Device Record Key: 510e06db-1d14-493d-acb5-af6f900fb1b0
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 14, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +49613691690
Email: info@tracoe.com

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