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

GUDID M724CCB7S611

Silicone-block tissue reconstructive material

Primary Device ID	M724CCB7S611
NIH Device Record Key	ebf35a70-da93-4bbc-a095-8bc54e8f6d47
Commercial Distribution Status	In Commercial Distribution
Brand Name	ContourFlex™ Calf Implant, Smooth (Aiache Style)
Version Model Number	Size: 18.6cm x 9.4cm x 2.2cm
Catalog Number	CCB7-S-61
Company DUNS	784664955
Company Name	IMPLANTECH ASSOCIATES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	M724CCB7S611 [Primary]

MIB	Elastomer, Silicone Block

Steralize Prior To Use	false
Device Is Sterile	true

M724NGBL20CVFNS1 - Silicone Block 2.0	2025-09-04 Silicone Block 2.0, Clear, Very Firm
M724NGBL20FFEZNS1 - Silicone Block 2.0	2025-09-04 Silicone Block 2.0, Fleshtone, Firm (EZ)
M724NGBL20FMEZNS1 - Silicone Block 2.0	2025-09-04 Silicone Block 2.0, Fleshtone, Medium (EZ)
M724NGBL20FSNS1 - Silicone Block 2.0	2025-09-04 Silicone Block 2.0, Fleshtone, Soft
M724NGBL20OVSNS1 - Silicone Block 2.0	2025-09-04 Silicone Block 2.0, Opaque, Very Soft
M724NGBL20RFM30EZNS1 - Silicone Block 2.0	2025-09-04 Silicone Block 2.0, Red Fleshtone Medium 30 (EZ)
M724NGBL20RFS15EZNS1 - Silicone Block 2.0	2025-09-04 Silicone Block 2.0, Red Fleshtone, Soft 15 (EZ)
M724NGBL20RFS20EZNS1 - Silicone Block 2.0	2025-09-04 Silicone Block 2.0, Red Fleshtone, Soft 20 (EZ)