Spectrum Designs Medical

FDA UDI

Class II (US FDA UDI)

by Spectrum Designs, Inc.

Identity

Trade Name: Spectrum Designs Medical FDA UDI
Generic Name: Silicone-block tissue reconstructive material FDA UDI
Device Name: Non-Sterile Carving Block, Solid Silicone, Clear, Firm Durometer, Small FDA UDI
Model / Reference: Carving Block, Clear, Firm Duro., Small FDA UDI
Description: Non-Sterile Carving Block, Solid Silicone, Clear, Firm Durometer, Small FDA UDI

Identifiers

Catalog Number: 600-114 FDA UDI
Primary DI / UDI-DI: B0186001141 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Silicone-block tissue reconstructive material

Spectrum Designs Medical by Spectrum Designs, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Silicone-block tissue reconstructive material.

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Powerflex™ Pectoral Implant — Implantech Associates, Inc. · Class II
SG Pec Sizer — Implantech Associates, Inc. · Class II
SG Pec Implant Style 4 — Implantech Associates, Inc. · Class II
Rectangular Carving Block 2.0 — Implantech Associates, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Spectrum Designs, Inc.

Sources (1)

FDA UDI 35029978-3a17-4f08-8695-9eafe466f455 35 fields · synced Jun 6, 2026