FDA.reportPublic FDA data

Perma Facial Implant

Primary DI
00853437006035
Brand
Perma Facial Implant
Company
SURGISIL, LLP
Model
PFI 4055
Device description
Silicone soft tissue facial implant
Published
2016-08-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODUFacial Implant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODUFacial ImplantGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071823000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071823000PERMA FACIAL IMPLANTSSurgisil2007-09-19ODU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853437006035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853437006035008534370060358534370060350853437006035

GMDN Terms#

Term, Definition table
TermDefinition
Malar prosthesisAn implantable device designed to augment or maintain the soft-tissue anatomy of the malar area (cheek). The device is typically a solid elastomer (e.g., silicone) available in several shapes and sizes for subdermal implantation in the malar area for cosmetic or reconstructive purposes following traumatic or disease/congenital deformation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length55Millimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
972.543.2497mikeal@surgisil.com

Regulatory Flags#

DUNS number
010030665
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853437006004Perma Facial ImplantPFI 30552018-02-27
00853437006011Perma Facial ImplantPFI 30602018-02-27
00853437006028Perma Facial ImplantPFI 30652017-11-16
00853437006042Perma Facial ImplantPFI 40602016-08-10
00853437006059Perma Facial ImplantPFI 40652017-09-19
00853437006066perma facial implantPFI 50552016-08-10
00853437006073Perma Facial implantPFI 50602016-08-10
00853437006080perma facial implantPFI 50652016-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00853437006004Perma Facial ImplantSURGISIL, LLPODU2018-02-27
00853437006011Perma Facial ImplantSURGISIL, LLPODU2018-02-27
00853437006028Perma Facial ImplantSURGISIL, LLPODU2017-11-16
00853437006059Perma Facial ImplantSURGISIL, LLPODU2017-09-19
00853437006042Perma Facial ImplantSURGISIL, LLPODU2016-08-10
00853437006066perma facial implantSURGISIL, LLPODU2016-08-10
00853437006073Perma Facial implantSURGISIL, LLPODU2016-08-10
00853437006080perma facial implantSURGISIL, LLPODU2016-08-10