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Encompass™ SRS Fibreplast™ Anterior Mask

FDA UDI

Class II (US FDA UDI)

by Qfix

Identity

Trade Name
Encompass™ SRS Fibreplast™ Anterior Mask FDA UDI
Generic Name
Patient positioning thermoplastic mould material FDA UDI
Device Name
Encompass™ Fibreplast® Variable Perf Open View Anterior Only FDA UDI
Model / Reference
10841962110928 FDA UDI
Description
Encompass™ Fibreplast® Variable Perf Open View Anterior Only FDA UDI

Identifiers

Catalog Number
RT-B889KYCF2A FDA UDI
Primary DI / UDI-DI
10841962110928 FDA UDI
FDA Product Code
LNH FDA UDI
OUO FDA UDI
KPS FDA UDI
JAK FDA UDI
JAI FDA UDI
LHN FDA UDI
IYE FDA UDI
GMDN Term
Patient positioning thermoplastic mould material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1000 FDA UDI
892.1200 FDA UDI
892.1750 FDA UDI
892.5770 FDA UDI
892.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Patient positioning thermoplastic mould material

Encompass™ SRS Fibreplast™ Anterior Mask by Qfix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient positioning thermoplastic mould material.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Qfix

Sources (1)

  • FDA UDI 2c6088c4-e315-407a-b875-1942ebe10ff1 35 fields · synced May 31, 2026