Gluteal Implant, Round, Textured, SDM CCB5-T-53

GUDID M724CCB5T531

Gluteal Implant

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material
Primary Device IDM724CCB5T531
NIH Device Record Key2fae5e58-3726-4450-9fc5-7603e5ee4c9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGluteal Implant, Round, Textured, SDM
Version Model NumberSize: 14.9cm x 14.9cm x 3.9cm
Catalog NumberCCB5-T-53
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
HIBCCM724CCB5T531 [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 Number3
Public Version Date2019-11-13
Device Publish Date2017-08-07

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M724CCB6T711Gluteal Implant
M724CCB5T531Gluteal Implant
M724CCB5T521Gluteal Implant
M724CCB5T511Gluteal Implant
M724CCB6T821Gluteal Implant
M724CCB6T811Gluteal Implant
M724CCB6T721Gluteal Implant
M724CCB5T561Gluteal Implant
M724CCB5T551Gluteal Implant
M724CCB5T541Gluteal Implant

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