AccessGUDID - DEVICE: ContourFlex™ Gluteal Implant (M724CCB50NS1)

GUDID

Device Identifier (DI) Information

Brand Name: ContourFlex™ Gluteal Implant
Version or Model: CCB5 / Size 0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CCB5-0-NS
Company Name: IMPLANTECH ASSOCIATES, INC.

Primary DI Number: M724CCB50NS1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784664955 *Terms of Use

Device Description: ContourFlex™ Gluteal Implant, Round

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45230	Silicone-block tissue reconstructive material	A non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-section or with curved surfaces. It may be carved or trimmed into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that involve soft-tissue or bone augmentation, or the formation of prosthetic implants (e.g., chin or malar). This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIB	Elastomer, Silicone Block

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052504	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c1fb2b68-bce1-40b0-93a3-82816a412a33
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 10, 2017