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Aquaplast RT™

FDA UDI

Class II (US FDA UDI)

by Qfix

Identity

Trade Name
Aquaplast RT™ FDA UDI
Generic Name
Patient positioning thermoplastic mould material FDA UDI
Device Name
Aquaplast Splt Slim U-Frame Gap, Std, 2.4mm FDA UDI
Model / Reference
RT-1779S-S3 FDA UDI
Description
Aquaplast Splt Slim U-Frame Gap, Std, 2.4mm FDA UDI

Identifiers

Catalog Number
RT-1779S-S3 FDA UDI
Primary DI / UDI-DI
10841962101469 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Patient positioning thermoplastic mould material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

Dimensions & Sizes

Size
Depth — 2.4 Millimeter FDA UDI

Category: Patient positioning thermoplastic mould material

Aquaplast RT™ 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 32d341b5-e906-4355-8508-788b786541f6 36 fields · synced May 31, 2026