Silicone Block SMCO-BL-2.0-OF

GUDID M724SMCOBL20OF1

Silicone Block 2.0 Opaque, Firm

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material
Primary Device IDM724SMCOBL20OF1
NIH Device Record Keyda0350dc-40c2-47c1-98c5-610ae42c1a8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Block
Version Model NumberSMCO-BL-2.0-OF
Catalog NumberSMCO-BL-2.0-OF
Company DUNS784664955
Company NameIMPLANTECH ASSOCIATES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM724SMCOBL20OF1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIBElastomer, Silicone Block

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M724SMCOBL20OF1]

Moist Heat or Steam Sterilization


[M724SMCOBL20OF1]

Moist Heat or Steam Sterilization


[M724SMCOBL20OF1]

Moist Heat or Steam Sterilization


[M724SMCOBL20OF1]

Moist Heat or Steam Sterilization


[M724SMCOBL20OF1]

Moist Heat or Steam Sterilization


[M724SMCOBL20OF1]

Moist Heat or Steam Sterilization


[M724SMCOBL20OF1]

Moist Heat or Steam Sterilization


[M724SMCOBL20OF1]

Moist Heat or Steam Sterilization


[M724SMCOBL20OF1]

Moist Heat or Steam Sterilization


[M724SMCOBL20OF1]

Moist Heat or Steam Sterilization


[M724SMCOBL20OF1]

Moist Heat or Steam Sterilization


[M724SMCOBL20OF1]

Moist Heat or Steam Sterilization


[M724SMCOBL20OF1]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-05
Device Publish Date2026-01-28

On-Brand Devices [Silicone Block]

M724BLKBSC51Silicone Block
M724BLKBSC41Silicone Block
M724BLKBSC31Silicone Block
M724BLKBSC21Silicone Block
M724BLKBSC11Silicone Block
M724SMCOBL20WVS1Silicone Block 2.0 White, Very Soft
M724SMCOBL20WF1Silicone Block 2.0 White, Firm
M724SMCOBL20OVS1Silicone Block 2.0 Opaque, Very Soft
M724SMCOBL20OF1Silicone Block 2.0 Opaque, Firm
M724SMCOBL20FF1Silicone Block 2.0 Fleshtone, Firm

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