FDA.reportPublic FDA data

Spectrum Designs Medical

Primary DI
B018400414S1
Brand
Spectrum Designs Medical
Company
SPECTRUM DESIGNS INC
Model
Dorsal Columella, Style 4
Catalog number
400-414S
Device description
Allergan Distributed
Published
2015-10-23
Public version status
Update
Distribution status
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
FZEProsthesis, Nose, Internal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B018400414S1PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
8056847678service@spectrumdesignsmedical
8056847678service@spectrumdesignsmedical.com

Regulatory Flags#

DUNS number
148681521
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B018400114S1Spectrum Designs MedicalDorsal Columella, Style 1400-114S2015-10-23
B018400214S1Spectrum Designs MedicalDorsal Columella, Style 2400-214S2015-10-23
B018400314S1Spectrum Designs MedicalDorsal Columella, Style 3400-314S2015-10-23
B018400514S1Spectrum Designs MedicalDorsal Columella, Style 5, size 1400-514S2015-10-23
B018400524S1Spectrum Designs MedicalDorsal Columella, Style 5, size 2400-524S2015-10-23
B018400534S1Spectrum Designs MedicalDorsal Columella, Style 5, size 3400-534S2015-10-23
B018400544S1Spectrum Designs MedicalDorsal Columella, Style 5, size 4400-544S2015-10-23
B018400614S1Spectrum Designs MedicalVoloshin Dorsal Columella, size 1400-614S2015-10-23
B018400624S1Spectrum Designs MedicalVoloshin Dorsal Columella, size 2400-624S2015-10-23
B018400634S1Spectrum Designs MedicalVoloshin Dorsal Columella, size 3400-634S2015-10-23
B018400644S1Spectrum Designs MedicalVoloshin Dorsal Columella, size 4400-644S2015-10-23
B018400654S1Spectrum Designs MedicalVoloshin Dorsal Columella, size 5400-654S2015-10-23
B018400664S1Spectrum Designs MedicalVoloshin Dorsal Columella, size 6400-664S2015-10-23
B018400714S1Spectrum Designs MedicalNasal Dorsum Style 7, size 1400-714S2015-10-23
B018400724S1Spectrum Designs MedicalNasal Dorsum Style 7, size 2400-724S2015-10-23
B018400734S1Spectrum Designs MedicalNasal Dorsum Style 7, size 3400-734S2015-10-23
B018400744S1Spectrum Designs MedicalNasal Dorsum Style 7, size 4400-744S2015-10-23
B018400754S1Spectrum Designs MedicalNasal Dorsum Style 7, size 5400-754S2015-10-23
B018400814S1Spectrum Designs MedicalNasal Dorsum Style 8, size 1400-814S2015-10-23
B018400824S1Spectrum Designs MedicalNasal Dorsum Style 8, size 2400-824S2015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09321502015615BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
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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