FDA.report

Spectrum Designs Medical

Primary DI
B018S250314S1
Brand
Spectrum Designs Medical
Company
SPECTRUM DESIGNS INC
Model
Curvilinear Chin, size 1
Catalog number
S250-314S
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FWPProsthesis, Chin, Internal

Product Code Classifications

CodeDeviceSpecialtyClass
FWPProsthesis, Chin, InternalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B018S250314S1PrimaryHIBCC0

GMDN Terms

TermDefinition
Chin prosthesisA sterile device implanted in the soft tissue of the chin to correct chin deformities or improve facial appearance. It is usually made of a polymer material.

Sterilization Methods

Method

Contacts

PhoneEmail
8056847678service@spectrumdesignsmedical

Regulatory Flags

DUNS number
148681521
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B018550111LT1Spectrum Designs MedicalPectoral 1, Aiache, Left, Size 1550-111LT2015-10-23
B018550111RT1Spectrum Designs MedicalPectoral 1, Aiache, Right, Size 1550-111RT2015-10-23
B018550121LT1Spectrum Designs MedicalPectoral 1, Aiache, Left, Size 2550-121LT2015-10-23
B018550121RT1Spectrum Designs MedicalPectoral 1, Aiache, Right, Size 2550-121RT2015-10-23
B018550131LT1Spectrum Designs MedicalPectoral 1, Aiache, Left, Size 3550-131LT2015-10-23
B018550131RT1Spectrum Designs MedicalPectoral 1, Aiache, Right, Size 3550-131RT2015-10-23
B018550141LT1Spectrum Designs MedicalPectoral 1, Aiache, Left, Size 4550-141LT2015-10-23
B018550141RT1Spectrum Designs MedicalPectoral 1, Aiache, Right, Size 4550-141RT2015-10-23
B018550411LT1Spectrum Designs MedicalPectoral 2, Novack, Left550-411LT2015-10-23
B018550411RT1Spectrum Designs MedicalPectoral 2, Novack, Right550-411RT2015-10-23
B018550511LT1Spectrum Designs MedicalPectoral 3, Novack, Left550-511LT2015-10-23
B018550511RT1Spectrum Designs MedicalPectoral 3, Novack, Right550-511RT2015-10-23
B018550611LT1Spectrum Designs MedicalPectoral 4, Aiache, Left, Size 1550-611LT2015-10-23
B018550611RT1Spectrum Designs MedicalPectoral 4, Aiache, Right, Size 1550-611RT2015-10-23
B018550621LT1Spectrum Designs MedicalPectoral 4, Aiache, Left, Size 2550-621LT2015-10-23
B018550621RT1Spectrum Designs MedicalPectoral 4, Aiache, Right, Size 2550-621RT2015-10-23
B018550631LT1Spectrum Designs MedicalPectoral 4, Aiache, Left, Size 3550-631LT2015-10-23
B018550631RT1Spectrum Designs MedicalPectoral 4, Aiache, Right, Size 3550-631RT2015-10-23
B018120214S1Spectrum Designs MedicalAnatomical Malar I, size 1120-214S2015-10-23
B018120224S1Spectrum Designs MedicalAnatomical Malar I, size 2120-224S2015-10-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B490400102Chin ImplantAartFWP2025-08-28
B490400103Chin ImplantAartFWP2025-08-28
B490400104Chin ImplantAartFWP2025-08-28
B490400201Chin ImplantAartFWP2025-08-28
B490400202Chin ImplantAartFWP2025-08-28
B490400301Chin ImplantAartFWP2025-08-28
B490400302Chin ImplantAartFWP2025-08-28
B490400303Chin ImplantAartFWP2025-08-28
B490400401Chin ImplantAartFWP2025-08-28
B490400402Chin ImplantAartFWP2025-08-28
B490400403Chin ImplantAartFWP2025-08-28
B490400404Chin ImplantAartFWP2025-08-28
B490400101Chin ImplantAartFWP2025-07-31
00888233026932HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233057158HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233057165HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233057172HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233057189HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233057196HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233062244HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233062695HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233062701HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233062718HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233063067HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233063111HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233063241HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233063845HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233064224HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233064446HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233064491HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04