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Sophysa

FDA UDI

Class I (US FDA UDI)

by Sophysa SA

Identity

Trade Name
Sophysa FDA UDI
Generic Name
Subcutaneous tunneller, single-use FDA UDI
Device Name
DISPOSABLE TUBUAR SHEATH FOR CATHETER PASSER 65 CM FDA UDI
Model / Reference
TUG-65 FDA UDI
Description
DISPOSABLE TUBUAR SHEATH FOR CATHETER PASSER 65 CM FDA UDI

Identifiers

Primary DI / UDI-DI
03760124131451 FDA UDI
FDA Product Code
GYK FDA UDI
GMDN Term
Subcutaneous tunneller, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
882.4545 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Subcutaneous tunneller, single-use

Sophysa by Sophysa SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Subcutaneous tunneller, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sophysa SA

Sources (1)

  • FDA UDI c32df144-f294-4ffc-870c-55bf54880c19 33 fields · synced May 31, 2026