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GLUTEAL IMPLANTS

PRODUCT NAME

Tissue reconstructive material, synthetic, silicone, block

 

INDICATION

Silicone Carving Block is a solid silicone implant intended for use in plastic surgery

to augment or reconstruct hip.

 

HOW TO USE

1) This product is intended for single use only.

2) Do not reuse explanted products.

3) A patient record label accompanies each device within the internal product packaging.

The patient record label may be attached to the patient's chart for identification purposes.

4) Do not use product if the package seal has been damaged.

5) Do not resterilize any product intended for implantation. Never, under any circumstances,

attempt to resterilize using ethylene oxide, which is know to cause adverse tissue reaction

if not completely removed for the implant.

6) The implant should be kept in such manner prior to surgery as to prevent contamination by lint,

towel, sponge, skin oils, talc and other surface contaminations which could cause foreign body

reactions.

7) Remove the implant from its package in an aseptic environment, using talc-free gloved hands.

Firmly hold outer thermoform tray

Grasp outer tyvek seal and peel back completely to the end seal

Drop sterile inner package in the sterile filed

When the implant is needed, open inner package in the same manner as the outer package

Lift the sterile implant from the inner tray well

8) Prior to use, keep the implant in the inner thermoform sealed tray to prevent contact with airborne dust

and surgical field particulate contaminants.

9) Do not implant damaged or contaminated implants.

10) Do not attempt to repair damaged products.

 

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