FDA.report

Spectrum Designs Medical

Primary DI
B018650191S1
Brand
Spectrum Designs Medical
Company
SPECTRUM DESIGNS INC
Model
Preform Contour Block I, Smooth, Size 9
Catalog number
650-191S
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
MIBElastomer, Silicone Block

Product Code Classifications

CodeDeviceSpecialtyClass
MIBElastomer, Silicone BlockEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B018650191S1PrimaryHIBCC0

GMDN Terms

TermDefinition
Silicone-block tissue reconstructive materialA non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-section or with curved surfaces. It may be carved or trimmed into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that involve soft-tissue or bone augmentation, or the formation of prosthetic implants (e.g., chin or malar). This is a single-use device.

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
M724SMCOBL20FF1Silicone BlockIMPLANTECH ASSOCIATES, INC.MIB2026-01-28
M724SMCOBL20OF1Silicone BlockIMPLANTECH ASSOCIATES, INC.MIB2026-01-28
M724SMCOBL20OVS1Silicone BlockIMPLANTECH ASSOCIATES, INC.MIB2026-01-28
M724SMCOBL20WF1Silicone BlockIMPLANTECH ASSOCIATES, INC.MIB2026-01-28
M724SMCOBL20WVS1Silicone BlockIMPLANTECH ASSOCIATES, INC.MIB2026-01-28
B490501101Gluteal ImplantAartMIB2025-09-02
B490501102Gluteal ImplantAartMIB2025-09-02
B490501103Gluteal ImplantAartMIB2025-09-02
B490501104Gluteal ImplantAartMIB2025-09-02
B490501105Gluteal ImplantAartMIB2025-09-02
B4905011053Gluteal ImplantAartMIB2025-09-02
B490501106Gluteal ImplantAartMIB2025-09-02
B4905011063Gluteal ImplantAartMIB2025-09-02
B490501201Gluteal ImplantAartMIB2025-09-02
B490501202Gluteal ImplantAartMIB2025-09-02
B490501203Gluteal ImplantAartMIB2025-09-02
B490501204Gluteal ImplantAartMIB2025-09-02
B490501205Gluteal ImplantAartMIB2025-09-02
B490501206Gluteal ImplantAartMIB2025-09-02
B4905012063Gluteal ImplantAartMIB2025-09-02
B490501300Gluteal ImplantAartMIB2025-09-02
B4905013003Gluteal ImplantAartMIB2025-09-02
B490501301Gluteal ImplantAartMIB2025-09-02
B4905013013Gluteal ImplantAartMIB2025-09-02
B490501302Gluteal ImplantAartMIB2025-09-02
B4905013023Gluteal ImplantAartMIB2025-09-02
B490501303Gluteal ImplantAartMIB2025-09-02
B4905013033Gluteal ImplantAartMIB2025-09-02
B490501304Gluteal ImplantAartMIB2025-09-02
B4905013043Gluteal ImplantAartMIB2025-09-02