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3D SCANNER TPR Option

FDA UDI

Class II (US FDA UDI)

by Sun Nuclear Corporation

Identity

Trade Name
3D SCANNER TPR Option FDA UDI
Generic Name
Accelerator system quality assurance device FDA UDI
Device Name
Accessory to the 1230 3D SCANNER. FDA UDI
Model / Reference
12300004Z FDA UDI
Description
Accessory to the 1230 3D SCANNER. FDA UDI

Identifiers

Catalog Number
12300004Z FDA UDI
Primary DI / UDI-DI
B01612300004Z0 FDA UDI
510(k) Number
K101992 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

3D SCANNER TPR Option by Sun Nuclear Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K101992 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sun Nuclear Corporation

Sources (1)

  • FDA UDI 7745924d-bdd5-4773-bd14-7e5cdcbfadd1 37 fields · synced Jun 8, 2026