Silicone Block

GUDID B097IMD006XL1

INTERNATIONAL MEDICAL DEVICES, INC.

Silicone-block tissue reconstructive material
Primary Device IDB097IMD006XL1
NIH Device Record Keyce1ab04a-2c44-4523-afbd-0972b6a61e3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Block
Version Model NumberExtra Large - Soft
Company DUNS080156251
Company NameINTERNATIONAL MEDICAL DEVICES, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com
Phone310-652-2600
Emailinfo@intlmeddevices.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB097IMD006XL1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIBElastomer, Silicone Block

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


[B097IMD006XL1]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-18
Device Publish Date2016-09-23

On-Brand Devices [Silicone Block]

B097IMD006XXL1Extra Extra Large - Soft
B097IMD006XLO1Extra Large - Extra Long - Soft
B097IMD006XL1Extra Large - Soft
B097IMD006LLO1Large - Extra Long - Soft
B097IMD006L1Large - Soft
B097IMD001XXL1Extra Extra Large - Extra Soft
B097IMD001XL1Extra Large - Extra Soft
B097IMD001L1Large - Extra Soft

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