Perma Facial Implant

GUDID 00853437006059

silicone soft tissue facial implant..

SURGISIL, LLP

Malar prosthesis
Primary Device ID00853437006059
NIH Device Record Keybe4c8a45-9a46-4b61-b2db-c20b5137ed3d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerma Facial Implant
Version Model NumberPFI 4065
Company DUNS010030665
Company NameSURGISIL, LLP
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com
Phone972.543.2497
Emailmikeal@surgisil.com

Device Dimensions

Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter
Length65 Millimeter
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100853437006059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODUFacial Implant

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-19

On-Brand Devices [Perma Facial Implant]

00853437006080silicone soft tissue facial implant
00853437006073silicone soft tissue facial implant
00853437006066silicone soft tissue facial implant
00853437006059silicone soft tissue facial implant..
00853437006042Silicone soft tissue facial implant
00853437006035Silicone soft tissue facial implant
00853437006028Silicone soft tissue facial implant..
00853437006011Silicone soft tissue facial implant..
00853437006004Silicone soft tissue facial implant..

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