Gluteal Implant, Round, Textured, SDM CCB5-T-52

GUDID M724CCB5T521

Silicone-block tissue reconstructive material

Primary Device ID	M724CCB5T521
NIH Device Record Key	feaf6c38-36e6-4918-921d-5958c433d80c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Gluteal Implant, Round, Textured, SDM
Version Model Number	Size: 12.6cm x 12.6cm x 3.7cm
Catalog Number	CCB5-T-52
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

Phone	1-800-733-0833
Email	info@implantech.com

Device Issuing Agency	Device ID
HIBCC	M724CCB5T521 [Primary]

MIB	Elastomer, Silicone Block

Steralize Prior To Use	false
Device Is Sterile	true