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Adaptor Plate for GMF

FDA UDI

Class II (US FDA UDI)

by Sun Nuclear Corp.

Identity

Trade Name
Adaptor Plate for GMF FDA UDI
Generic Name
Accelerator system quality assurance device FDA UDI
Device Name
Accessory to the 1177 MapCHECK2. FDA UDI
Model / Reference
1122AZ FDA UDI
Description
Accessory to the 1177 MapCHECK2. FDA UDI

Identifiers

Catalog Number
1122AZ FDA UDI
Primary DI / UDI-DI
B0161122AZ0 FDA UDI
510(k) Number
K131466 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Accelerator system quality assurance device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Adaptor Plate for GMF by Sun Nuclear Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K131466 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sun Nuclear Corp.

Sources (1)

  • FDA UDI 7d701cd5-05ce-48c4-9e9f-a7a4fbf20413 37 fields · synced Jun 8, 2026