Home GUDID B018650151T1 Spectrum Designs Medical
Primary DI B018650151T1
Brand Spectrum Designs Medical
Company SPECTRUM DESIGNS INC
Model Preform Contour Block I, Textured, Size 5
Catalog number 650-151T
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 Product Codes# Code, Name table Code Name MIB Elastomer, Silicone Block
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MIB Elastomer, Silicone Block Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B018650151T1 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Silicone-block tissue reconstructive material A 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.
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 DI, Brand, Model table Primary DI Brand Model Catalog Published B018550111LT1 Spectrum Designs Medical Pectoral 1, Aiache, Left, Size 1 550-111LT 2015-10-23 B018550111RT1 Spectrum Designs Medical Pectoral 1, Aiache, Right, Size 1 550-111RT 2015-10-23 B018550121LT1 Spectrum Designs Medical Pectoral 1, Aiache, Left, Size 2 550-121LT 2015-10-23 B018550121RT1 Spectrum Designs Medical Pectoral 1, Aiache, Right, Size 2 550-121RT 2015-10-23 B018550131LT1 Spectrum Designs Medical Pectoral 1, Aiache, Left, Size 3 550-131LT 2015-10-23 B018550131RT1 Spectrum Designs Medical Pectoral 1, Aiache, Right, Size 3 550-131RT 2015-10-23 B018550141LT1 Spectrum Designs Medical Pectoral 1, Aiache, Left, Size 4 550-141LT 2015-10-23 B018550141RT1 Spectrum Designs Medical Pectoral 1, Aiache, Right, Size 4 550-141RT 2015-10-23 B018550411LT1 Spectrum Designs Medical Pectoral 2, Novack, Left 550-411LT 2015-10-23 B018550411RT1 Spectrum Designs Medical Pectoral 2, Novack, Right 550-411RT 2015-10-23 B018550511LT1 Spectrum Designs Medical Pectoral 3, Novack, Left 550-511LT 2015-10-23 B018550511RT1 Spectrum Designs Medical Pectoral 3, Novack, Right 550-511RT 2015-10-23 B018550611LT1 Spectrum Designs Medical Pectoral 4, Aiache, Left, Size 1 550-611LT 2015-10-23 B018550611RT1 Spectrum Designs Medical Pectoral 4, Aiache, Right, Size 1 550-611RT 2015-10-23 B018550621LT1 Spectrum Designs Medical Pectoral 4, Aiache, Left, Size 2 550-621LT 2015-10-23 B018550621RT1 Spectrum Designs Medical Pectoral 4, Aiache, Right, Size 2 550-621RT 2015-10-23 B018550631LT1 Spectrum Designs Medical Pectoral 4, Aiache, Left, Size 3 550-631LT 2015-10-23 B018550631RT1 Spectrum Designs Medical Pectoral 4, Aiache, Right, Size 3 550-631RT 2015-10-23 B018120214S1 Spectrum Designs Medical Anatomical Malar I, size 1 120-214S 2015-10-23 B018120224S1 Spectrum Designs Medical Anatomical Malar I, size 2 120-224S 2015-10-23
Other Devices Sharing Product Codes#