Spectrum Designs Medical 400-414S

GUDID B018400414S1

Allergan Distributed

SPECTRUM DESIGNS INC

Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable
Primary Device IDB018400414S1
NIH Device Record Keyef5bbb77-cb62-462d-adef-a09599e7d4a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpectrum Designs Medical
Version Model NumberDorsal Columella, Style 4
Catalog Number400-414S
Company DUNS148681521
Company NameSPECTRUM DESIGNS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8056847678
Emailservice@spectrumdesignsmedical
Phone8056847678
Emailservice@spectrumdesignsmedical
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com
Phone8056847678
Emailservice@spectrumdesignsmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB018400414S1 [Primary]

FDA Product Code

FZEProsthesis, Nose, Internal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-23

On-Brand Devices [Spectrum Designs Medical]

B018S400984SH1Dorsal Columella Style 9, H
B018S400974SG1Dorsal Columella Style 9, G
B018S400964SF1Dorsal Columella Style 9, F
B018S400954SE1Dorsal Columella Style 9, E
B018S400944SD1Dorsal Columella Style 9, D
B018S400934SC1Dorsal Columella Style 9, C
B018S400924SB1Dorsal Columella Style 9, B
B018S400914SA1Dorsal Columella Style 9, A
B018S400824S1Nasal Dorsum Style 8, size 2
B018S400814S1Nasal Dorsum Style 8, size 1
B018S400754S1Nasal Dorsum Style 7, size 5
B018S400744S1Nasal Dorsum Style 7, size 4
B018S400734S1Nasal Dorsum Style 7, size 3
B018S400724S1Nasal Dorsum Style 7, size 2
B018S400714S1Nasal Dorsum Style 7, size 1
B018S400664S1Voloshin Dorsal Columella, size 6
B018S400654S1Voloshin Dorsal Columella, size 5
B018S400644S1Voloshin Dorsal Columella, size 4
B018S400634S1Voloshin Dorsal Columella, size 3
B018S400624S1Voloshin Dorsal Columella, size 2
B018S400614S1Voloshin Dorsal Columella, size 1
B018S400544S1Dorsal Columella, Style 5, size 4
B018S400534S1Dorsal Columella, Style 5, size 3
B018S400524S1Dorsal Columella, Style 5, size 2
B018S400514S1Dorsal Columella, Style 5, size 1
B018S400414S1Dorsal Columella, Style 4
B018S400314S1Dorsal Columella, Style 3
B018S400214S1Dorsal Columella, Style 2
B018S400114S1Dorsal Columella, Style 1
B018S250944S1Concave Back Chin, size 4
B018S250934S1Concave Back Chin, size 3
B018S250924S1Concave Back Chin, size 2
B018S250914S1Concave Back Chin, size 1
B018S250854S1Bilateral Groove Chin, size 5
B018S250844S1Bilateral Groove Chin, size 4
B018S250834S1Bilateral Groove Chin, size 3
B018S250824S1Bilateral Groove Chin, size 2
B018S250814S1Bilateral Groove Chin, size 1
B018S250784S1Anterior Mandibular Groove Jowl, size 3
B018S250774S1Anterior Mandibular Groove Jowl, size 2
B018S250764S1Anterior Mandibular Groove Jowl, size 1
B018S250634S1Cleft Chin, size 3
B018S250624S1Cleft Chin, size 2
B018S250614S1Cleft Chin, size 1
B018S250524S1Symmetrical Chin, size 2
B018S250514S1Symmetrical Chin, size 1
B018S250424S1Articulated Chin, size 2
B018S250414S1Articulated Chin, size 1
B018S250364S1Curvilinear Chin, size 6
B018S250354S1Curvilinear Chin, size 5

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.