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Alta

FDA UDI

Class II (US FDA UDI)

by Qfix

Identity

Trade Name
Alta FDA UDI
Generic Name
Indexed-immobilization patient positioning system FDA UDI
Device Name
Alta Silverman Adapter FDA UDI
Model / Reference
RT-4800-03 FDA UDI
Description
Alta Silverman Adapter FDA UDI

Identifiers

Catalog Number
RT-4800-03 FDA UDI
Primary DI / UDI-DI
00841962119597 FDA UDI
510(k) Number
K193243 FDA UDI
FDA Product Code
FRZ FDA UDI
IYE FDA UDI
JAI FDA UDI
JAK FDA UDI
KPS FDA UDI
LHN FDA UDI
LNH FDA UDI
OUO FDA UDI
GMDN Term
Indexed-immobilization patient positioning system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6775 FDA UDI
892.5050 FDA UDI
892.5770 FDA UDI
892.1750 FDA UDI
892.1200 FDA UDI
892.1000 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
MRI Safety
MR Safe FDA UDI

Category: Indexed-immobilization patient positioning system

Alta by Qfix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indexed-immobilization patient positioning system.

Cleared under the same submission

K193243 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Qfix

Sources (1)

  • FDA UDI ce42af3f-753b-4e55-9a0f-36874cf2e936 36 fields · synced Jun 8, 2026