Silicone Block

FDA UDI

Class II (US FDA UDI)

by International Medical Devices, Inc.

Identity

Trade Name: Silicone Block FDA UDI
Generic Name: Silicone-block tissue reconstructive material FDA UDI
Model / Reference: Extra Extra Large - Semi Soft FDA UDI

Identifiers

Primary DI / UDI-DI: B097IMD009XXL1 FDA UDI
510(k) Number: K042380 FDA UDI
K162624 FDA UDI
K181387 FDA UDI
K220760 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

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Dry Heat Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Silicone-block tissue reconstructive material

Silicone Block by International Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Silicone-block tissue reconstructive material.

SG Gluteal Implant — Implantech Associates, Inc. · Class II
Gluteal Implant — Aart · Class II
Contoured Carving Block — Implantech Associates, Inc. · Class II
ContourFlex™ Calf Implant Sizer — Implantech Associates, Inc. · Class II
Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
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

Cleared under the same submission

K042380 also covers:

K162624 also covers:

K181387 also covers:

K220760 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: International Medical Devices, Inc.

Sources (1)

FDA UDI 5a0866a1-5e37-4ede-9a43-08d3f45d2a7f 34 fields · synced Jun 1, 2026