ContourFlex™ Calf Implant, Smooth (Aiache Style) CCB7-S-61

GUDID M724CCB7S611

Calf Implant

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material
Primary Device IDM724CCB7S611
NIH Device Record Keyebf35a70-da93-4bbc-a095-8bc54e8f6d47
Commercial Distribution StatusIn Commercial Distribution
Brand NameContourFlex™ Calf Implant, Smooth (Aiache Style)
Version Model NumberSize: 18.6cm x 9.4cm x 2.2cm
Catalog NumberCCB7-S-61
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 Datetrue
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
Phone1-800-733-0833
Emailinfo@implantech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM724CCB7S611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIBElastomer, Silicone Block

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-07
Device Publish Date2021-03-30

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