ContourFlex™ Gluteal Implant, Anatomical (Teardrop) CCB6-2

GUDID M724CCB621

Contoured Carving Block Implant

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material
Primary Device IDM724CCB621
NIH Device Record Keyf306e01d-bcb0-4d87-927f-02584cc884cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameContourFlex™ Gluteal Implant, Anatomical (Teardrop)
Version Model NumberSize 2
Catalog NumberCCB6-2
Company DUNS784664955
Company NameIMPLANTECH ASSOCIATES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-733-0833
Emailinfo@implantech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM724CCB621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIBElastomer, Silicone Block

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-14
Device Publish Date2015-09-24

On-Brand Devices [ContourFlex™ Gluteal Implant, Anatomical (Teardrop)]

M724CCB621Contoured Carving Block Implant
M724CCB611Contoured Carving Block Implant
M724CCB631Contoured Carving Block Implant
M724CCB641Contoured Carving Block Implant

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.