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AART Silicone Carving Block

FDA UDI

Class II (US FDA UDI)

by Aart

Identity

Trade Name
AART Silicone Carving Block FDA UDI
Generic Name
Silicone-block tissue reconstructive material FDA UDI
Device Name
SCI Sty 8 Sz 3 Sterile FDA UDI
Model / Reference
A FDA UDI
Description
SCI Sty 8 Sz 3 Sterile FDA UDI

Identifiers

Catalog Number
600-803A FDA UDI
Primary DI / UDI-DI
B490600803A0 FDA UDI
510(k) Number
K021820 FDA UDI
FDA Product Code
MIB FDA UDI
GMDN Term
Silicone-block tissue reconstructive material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3620 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Dry Heat Sterilization FDA UDI

AART Silicone Carving Block by Aart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K021820 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aart

Sources (1)

  • FDA UDI 42603ae7-ffac-4d0e-ae8e-ae5cbf44d567 37 fields · synced May 30, 2026