ContourFlex™ Gluteal Implant Sizer Round CCB5-SIZ-6-NS

GUDID M724CCB5SIZ6NS1

ContourFlex™ Gluteal Implant Sizer Round

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 Silicone-block tissue reconstructive material
Primary Device IDM724CCB5SIZ6NS1
NIH Device Record Key48c4abc7-d533-4cbb-9a2c-eaf4b4822d5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameContourFlex™ Gluteal Implant Sizer Round
Version Model NumberCCB5-SIZ-6
Catalog NumberCCB5-SIZ-6-NS
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 Datefalse
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
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com
Phone1-800-733-0833
Emailinfo@implantech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM724CCB5SIZ6NS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIBElastomer, Silicone Block

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


[M724CCB5SIZ6NS1]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-28
Device Publish Date2024-05-20

On-Brand Devices [ContourFlex™ Gluteal Implant Sizer Round]

M724CCB5SIZ6NS1ContourFlex™ Gluteal Implant Sizer Round
M724CCB5SIZ5NS1ContourFlex™ Gluteal Implant Sizer Round

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