FDA.reportPublic FDA data

AART Silicone Sheeting

Primary DI
B4902011230B0
Brand
AART Silicone Sheeting
Company
Aart
Model
B
Catalog number
201-12-30B
Device description
"Silicone Sheeting,12""x12""x.030 R Sterile"
Published
2016-12-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIBELASTOMER, SILICONE BLOCK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIBElastomer, Silicone BlockEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022223000AART SILICONE SHEETINGAesthetic and Reconstructive Technologies, Inc.2002-08-08MIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B4902011230B0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Silicone-sheet tissue reconstructive material, sterileA sterile, flat stretch of silicone elastomer typically modified to suit the patient anatomy and intended to be implanted for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile), and may be cut into different sizes and shapes for various reconstructive otorhinolaryngology/head and neck surgery applications (e.g., repair of nasal septums, perforated eardrums).

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(775)853-6800customer.service@aartinc.net

Regulatory Flags#

DUNS number
091356894
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B490501101Gluteal ImplantE501-1012025-09-02
B490501102Gluteal ImplantE501-1022025-09-02
B490501103Gluteal ImplantE501-1032025-09-02
B490501104Gluteal ImplantE501-1042025-09-02
B490501105Gluteal ImplantE501-1052025-09-02
B4905011053Gluteal ImplantD501-105-32025-09-02
B490501106Gluteal ImplantE501-1062025-09-02
B4905011063Gluteal ImplantD501-106-32025-09-02
B490501201Gluteal ImplantE501-2012025-09-02
B490501202Gluteal ImplantE501-2022025-09-02
B490501203Gluteal ImplantE501-2032025-09-02
B490501204Gluteal ImplantE501-2042025-09-02
B490501205Gluteal ImplantE501-2052025-09-02
B490501206Gluteal ImplantE501-2062025-09-02
B4905012063Gluteal ImplantB501-206-32025-09-02
B490501300Gluteal ImplantE501-3002025-09-02
B4905013003Gluteal ImplantD501-300-32025-09-02
B490501301Gluteal ImplantE501-3012025-09-02
B4905013013Gluteal ImplantD501-301-32025-09-02
B490501302Gluteal ImplantE501-3022025-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M724CCB5SIZ7NS1ContourFlex™ Gluteal Implant Sizer RoundIMPLANTECH ASSOCIATES, INC.MIB2024-05-20
M724CCB11SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB12SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB13SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB14SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB15SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB21SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB22SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB23SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB31SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB32SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB33SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB41SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB42SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB43SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB44SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB45SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZK1NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZNC1NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZNC3NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB7SIZ1NS1ContourFlex™ Calf Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB7SIZ3NS1ContourFlex™ Calf Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB50NS1ContourFlex™ Gluteal ImplantIMPLANTECH ASSOCIATES, INC.MIB2017-07-10
M724CCB45NS1Contoured Carving BlockIMPLANTECH ASSOCIATES, INC.MIB2016-04-22
M72423700071AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700101AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700151AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700201AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700301AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700401AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24