ContourFlex™ Gluteal Implant Sizer CCB5-54-SIZ-NS

GUDID M724CCB554SIZNS1

Gluteal Implant Sizer

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 Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material

Primary Device ID	M724CCB554SIZNS1
NIH Device Record Key	3dd8ef42-ea3e-453d-a7b6-b59d19af1edc
Commercial Distribution Status	In Commercial Distribution
Brand Name	ContourFlex™ Gluteal Implant Sizer
Version Model Number	Round / Size 54
Catalog Number	CCB5-54-SIZ-NS
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	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724CCB554SIZNS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K982688

FDA Product Code

MIB	Elastomer, Silicone Block