FDA.reportPublic FDA data

Nasal Implant

Primary DI
B049N8F0
Brand
Nasal Implant
Company
Hanson Medical, Inc.
Model
N - 8 F
Catalog number
N - 8 F
Device description
Non-sterile, silicone, nasal implant.
Published
2015-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K973573000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973573000DURALASTIC ANATOMICAL NASAL IMPLANTSHanson Medical, Inc.1997-11-13FZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B049N8F0PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(800)771-2215erik@hansonmedical.com

Regulatory Flags#

DUNS number
058759296
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B049N101F0Nasal ImplantN 10-1 FN 10-1 F2015-10-07
B049N101S0Nasal ImplantN 10-1 SN 10-1 S2015-10-07
B049N101W0Nasal ImplantN 10-1 WN 10-1 W2015-10-07
B049N102F0Nasal ImplantN 10-2 FN 10-2 F2015-10-07
B049N102S0Nasal ImplantN 10-2 SN 10-2 S2015-10-07
B049N102W0Nasal ImplantN 10-2 WN 10-2 W2015-10-07
B049N11F0Nasal ImplantN - 11 FN - 11 F2015-10-07
B049N11S0Nasal ImplantN - 11 SN - 11 S2015-10-07
B049N11W0Nasal ImplantN - 11 WN - 11 W2015-10-07
B049N121F0Nasal ImplantN 12-1 FN 12-1 F2015-10-07
B049N121S0Nasal ImplantN 12-1 SN 12-1 S2015-10-07
B049N121W0Nasal ImplantN 12-1 WN 12-1 W2015-10-07
B049N122F0Nasal ImplantN 12-2 FN 12-2 F2015-10-07
B049N122S0Nasal ImplantN 12-2 SN 12-2 S2015-10-07
B049N122W0Nasal ImplantN 12-2 WN 12-2 W2015-10-07
B049N131F0Nasal ImplantN 13-1 FN 13-1 F2015-10-07
B049N131S0Nasal ImplantN 13-1 SN 13-1 S2015-10-07
B049N132F0Nasal ImplantN 13-2 FN 13-2 F2015-10-07
B049N132S0Nasal ImplantN 13-2 SN 13-2 S2015-10-07
B049N133F0Nasal ImplantN 13-3 FN 13-3 F2015-10-07

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
00841036204181HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-15
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