Spectrum Designs Medical 600-421

GUDID B0186004211

Non-Sterile Carving Block, Solid Silicone, White, Soft Durometer, Medium Size

SPECTRUM DESIGNS INC

Silicone-block tissue reconstructive material

• Primary Device ID: B0186004211
• NIH Device Record Key: 2a3c24cd-561c-4bdb-a4fb-75bbf1ae7811
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectrum Designs Medical
• Version Model Number: Carving Block, White, Soft Duro., Medium
• Catalog Number: 600-421
• Company DUNS: 148681521
• Company Name: SPECTRUM DESIGNS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8056847678
• Email: service@spectrumdesignsmedical
• Phone: 8056847678
• Email: service@spectrumdesignsmedical

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0186004211 [Primary]

FDA Product Code

• MIB: Elastomer, Silicone Block

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B0186004211]

Moist Heat or Steam Sterilization

[B0186004211]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-23

On-Brand Devices [Spectrum Designs Medical]

• B018S400984SH1: Dorsal Columella Style 9, H
• B018S400974SG1: Dorsal Columella Style 9, G
• B018S400964SF1: Dorsal Columella Style 9, F
• B018S400954SE1: Dorsal Columella Style 9, E
• B018S400944SD1: Dorsal Columella Style 9, D
• B018S400934SC1: Dorsal Columella Style 9, C
• B018S400924SB1: Dorsal Columella Style 9, B
• B018S400914SA1: Dorsal Columella Style 9, A
• B018S400824S1: Nasal Dorsum Style 8, size 2
• B018S400814S1: Nasal Dorsum Style 8, size 1
• B018S400754S1: Nasal Dorsum Style 7, size 5
• B018S400744S1: Nasal Dorsum Style 7, size 4
• B018S400734S1: Nasal Dorsum Style 7, size 3
• B018S400724S1: Nasal Dorsum Style 7, size 2
• B018S400714S1: Nasal Dorsum Style 7, size 1
• B018S400664S1: Voloshin Dorsal Columella, size 6
• B018S400654S1: Voloshin Dorsal Columella, size 5
• B018S400644S1: Voloshin Dorsal Columella, size 4
• B018S400634S1: Voloshin Dorsal Columella, size 3
• B018S400624S1: Voloshin Dorsal Columella, size 2
• B018S400614S1: Voloshin Dorsal Columella, size 1
• B018S400544S1: Dorsal Columella, Style 5, size 4
• B018S400534S1: Dorsal Columella, Style 5, size 3
• B018S400524S1: Dorsal Columella, Style 5, size 2
• B018S400514S1: Dorsal Columella, Style 5, size 1
• B018S400414S1: Dorsal Columella, Style 4
• B018S400314S1: Dorsal Columella, Style 3
• B018S400214S1: Dorsal Columella, Style 2
• B018S400114S1: Dorsal Columella, Style 1
• B018S250944S1: Concave Back Chin, size 4
• B018S250934S1: Concave Back Chin, size 3
• B018S250924S1: Concave Back Chin, size 2
• B018S250914S1: Concave Back Chin, size 1
• B018S250854S1: Bilateral Groove Chin, size 5
• B018S250844S1: Bilateral Groove Chin, size 4
• B018S250834S1: Bilateral Groove Chin, size 3
• B018S250824S1: Bilateral Groove Chin, size 2
• B018S250814S1: Bilateral Groove Chin, size 1
• B018S250784S1: Anterior Mandibular Groove Jowl, size 3
• B018S250774S1: Anterior Mandibular Groove Jowl, size 2
• B018S250764S1: Anterior Mandibular Groove Jowl, size 1
• B018S250634S1: Cleft Chin, size 3
• B018S250624S1: Cleft Chin, size 2
• B018S250614S1: Cleft Chin, size 1
• B018S250524S1: Symmetrical Chin, size 2
• B018S250514S1: Symmetrical Chin, size 1
• B018S250424S1: Articulated Chin, size 2
• B018S250414S1: Articulated Chin, size 1
• B018S250364S1: Curvilinear Chin, size 6
• B018S250354S1: Curvilinear Chin, size 5