FDA.reportPublic FDA data

AART Nasal Implant

Primary DI
B490402101B0
Brand
AART Nasal Implant
Company
Aart
Model
B
Catalog number
402-101B
Device description
Nasal Sty 1 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
FZEPROSTHESIS, NOSE, INTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZEProsthesis, Nose, InternalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021418000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021418000AART NASAL IMPLANTAesthetic and Reconstructive Technologies, Inc.2002-07-02FZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B490402101B0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nasal implant, synthetic polymer, non-bioabsorbableA non-bioabsorbable device intended to be implanted beneath the skin of the nose (e.g., between the nasal mucosa and the cartilage) to augment or restore the cosmetic appearance and/or function of the nose, by providing structural support to the cartilage. It is a shaped device made of synthetic polymer materials (e.g., solid silicone rubber).

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
B490100101Dimisil Scar GelA100-1012026-06-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09321502015615BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502020732BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502021760BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502021777BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502034579BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040075BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040082BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040099BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
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00841036203955HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203962HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203979HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203986HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203849HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-09
00841036203856HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-09
00841036203689HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203771HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203788HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203795HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203801HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203580HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203597HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203603HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203610HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203627HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203634HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203351HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04
00841036203368HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04
00841036203375HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04
00841036203382HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04