FDA.reportPublic FDA data

Spectrum Designs Medical

Primary DI
B018650121T1
Brand
Spectrum Designs Medical
Company
SPECTRUM DESIGNS INC
Model
Preform Contour Block I, Textured, Size 2
Catalog number
650-121T
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
MIBElastomer, Silicone Block

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIBElastomer, Silicone BlockEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B018650121T1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 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
B018400414S1Spectrum Designs MedicalDorsal Columella, Style 4400-414S2015-10-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M724CCB5SIZ7NS1ContourFlex™ Gluteal Implant Sizer RoundIMPLANTECH ASSOCIATES, INC.MIB2024-05-20
M724CCB11SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB12SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB13SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB14SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB15SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB21SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB22SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB23SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB31SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB32SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB33SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB41SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB42SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB43SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB44SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB45SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZK1NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZNC1NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZNC3NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB7SIZ1NS1ContourFlex™ Calf Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB7SIZ3NS1ContourFlex™ Calf Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB50NS1ContourFlex™ Gluteal ImplantIMPLANTECH ASSOCIATES, INC.MIB2017-07-10
M724CCB45NS1Contoured Carving BlockIMPLANTECH ASSOCIATES, INC.MIB2016-04-22
M72423700071AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700101AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700151AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700201AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700301AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700401AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24