FDA.reportPublic FDA data

Shirakabe Nasal Implant, 3 Pack

Primary DI
M724SNIL1PAK1
Brand
Shirakabe Nasal Implant, 3 Pack
Company
IMPLANTECH ASSOCIATES, INC.
Model
Size: Large
Catalog number
SNI-L1-PAK
Device description
Nasal Implant
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZEProsthesis, Nose, Internal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZEProsthesis, Nose, InternalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941960000IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE IIImplantech Associates, Inc.1994-08-17FZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M724SNIL1PAK1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nasal cartilage support implant, non-bioabsorbableA non-bioabsorbable device intended to be implanted beneath the skin of the nose (e.g., between the nasal mucosa and the cartilage) to augment or restore the cosmetic appearance and/or function of the nose, by providing structural support to the cartilage. It is a shaped device made of synthetic polymer materials (e.g., solid silicone rubber).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-733-0833info@implantech.com

Regulatory Flags#

DUNS number
784664955
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M724MCTBL10GF11Silicone Block, Grey, Firm 50 (EZ)Size: 14.5cm x 7.7cm x 1.0 cmMCT-BL-1.0-GF12026-04-16
M724MCTBL10GF21Silicone Block, Grey, Firm 50 (EZ)Size: 13.6cm x 5.8cm x 1.0cmMCT-BL-1.0-GF22026-04-16
M724MCTBL10OF1Silicone Block, Opaque, Firm 40 (EZ)Size: 13.6cm x 5.8cm x 1.0cmMCT-BL-1.0-OF2026-04-16
M724MCTBL13GM1Silicone Block, Grey, Medium 35 (EZ)Size: 15.0cm x 7.6cm x 1.3cmMCT-BL-1.3-GM2026-04-16
M724SMCOBL20FF1Silicone BlockSMCO-BL-2.0-FFSMCO-BL-2.0-FF2026-01-28
M724SMCOBL20OF1Silicone BlockSMCO-BL-2.0-OFSMCO-BL-2.0-OF2026-01-28
M724SMCOBL20OVS1Silicone BlockSMCO-BL-2.0-OVSSMCO-BL-2.0-OVS2026-01-28
M724SMCOBL20WF1Silicone BlockSMCO-BL-2.0-WFSMCO-BL-2.0-WF2026-01-28
M724SMCOBL20WVS1Silicone BlockSMCO-BL-2.0-WVSSMCO-BL-2.0-WVS2026-01-28
M724SLV6341Gelzone® Shoulder SleeveSLV634SLV6342023-06-22
M724NGBL20WMEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-WM-EZ-NS2025-08-27
M724NGBL20CVFNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-CVF-NS2025-08-27
M724NGBL20FFEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-FF-EZ-NS2025-08-27
M724NGBL20FMEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-FM-EZ-NS2025-08-27
M724NGBL20FSNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-FS-NS2025-08-27
M724NGBL20OVSNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-OVS-NS2025-08-27
M724NGBL20RFM30EZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFM30-EZ-NS2025-08-27
M724NGBL20RFS15EZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFS15-EZ-NS2025-08-27
M724NGBL20RFS20EZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFS20-EZ-NS2025-08-27
M724NGBL20RFSEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFS-EZ-NS2025-08-27

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Primary DI, Brand, Company table
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09321502034579BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040075BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040082BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040099BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
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00841036203986HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
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00841036203689HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203771HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203788HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
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00841036203801HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
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00841036203597HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
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00841036203610HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203627HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203634HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203351HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04
00841036203368HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04
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00841036203382HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04