TRACOE twist REF 501-06-X

by Tracoe medical GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04035324017881 UDI-DI	Date18 Oct 2015Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: TRACOE twist
Generic Name: Tracheostomy tube, non-reinforced, non-customized, single-use
Model / Ref / Catalog: REF 501-06-X

Primary DI / UDI-DI: 04035324017881
510(k) Number: K961449
FDA Product Code: JOH
GMDN Term: Tracheostomy tube, non-reinforced, non-customized, single-use

Device Class: Class II
Regulation Number: 868.5800
GUDID distribution status: In Commercial Distribution

Size: Lumen/Inner Diameter — 6.0 Millimeter

Other devices from Tracoe medical GmbH

TRACOE silcosoft REF 373-3.5-C30

Class II
TRACOE silcosoft REF 371-3.5-C36

Class II
TRACOE vario REF 455-09

Class II
TRACOE comfort REF 888-105-10-1D

Class II
TRACOE twist plus REF 888-316-07

Class II
TRACOE silcosoft REF 370-3.0-C50

Class II

See all devices from Tracoe medical GmbH →

Properties

Sterile
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (10)

Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Manufacturing Date: No