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TRACOE silcosoft

FDA UDI

Class II (US FDA UDI)

by Tracoe medical GmbH

Identity

Trade Name
TRACOE silcosoft FDA UDI
Generic Name
Tracheostomy tube, non-reinforced, non-customized, single-use FDA UDI
Device Name
Tracheostomy Tube for Children FDA UDI
Model / Reference
REF 373-3.0-C45 FDA UDI
Description
Tracheostomy Tube for Children FDA UDI

Identifiers

Catalog Number
REF 373-3.0-C45 FDA UDI
Primary DI / UDI-DI
04035324032297 FDA UDI
510(k) Number
K172720 FDA UDI
FDA Product Code
JOH FDA UDI
GMDN Term
Tracheostomy tube, non-reinforced, non-customized, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5800 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 3.0 Millimeter FDA UDI

TRACOE silcosoft by Tracoe medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K172720 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tracoe medical GmbH

Sources (1)

  • FDA UDI 89a70705-2141-4600-8104-0c874d5ab7ff 39 fields · synced May 31, 2026