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Posterior Mask

FDA UDI

Class II (US FDA UDI)

by Aktina Corp.

Identity

Trade Name
Posterior Mask FDA UDI
Generic Name
Patient positioning thermoplastic mould material FDA UDI
Model / Reference
40-731 FDA UDI

Identifiers

Primary DI / UDI-DI
B365407310 FDA UDI
510(k) Number
K192102 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Patient positioning thermoplastic mould material

Posterior Mask by Aktina Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient positioning thermoplastic mould material.

Cleared under the same submission

K192102 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aktina Corp.

Sources (1)

  • FDA UDI f93e3b50-6654-4387-bbfc-6d8cf3e71aed 33 fields · synced Jun 1, 2026