FDA.reportPublic FDA data

SURGIFORM

Primary DI
00850987007871
Brand
SURGIFORM
Company
SURGICAL TECHNOLOGY LABORATORIES INC
Model
CND-18CC
Catalog number
CND-18CC
Device description
CND-18CC Nasal Dorsal Series CC Silicone Implants
Published
2016-09-24
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

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
K983755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983755000NASAL DORSAL SERIESSurgical Technology Laboratories, Inc.1998-11-20FZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850987007871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850987007871008509870078718509870078710850987007871

GMDN Terms#

Term, Definition table
TermDefinition
Nasal implant, synthetic polymer, 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

Regulatory Flags#

DUNS number
080380106
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
00854804007006SFAMSFAM603SFAM6032017-01-05
00854804007013SFAMSFAM803SFAM8032017-01-05
00854804007037SFAMSFAM503SFAM5032017-01-05
00854804007259SFAM PledgetPLG-6-RD2025-07-15
00854804007129SurgiPlast Nasal SplintSurgiPlast - Large - Skin Color - 1.6mm2024-09-30
00854804007136SurgiPlast Nasal SplintSurgiPlast - Large - Skin Color - 2.0mm2024-09-30
00854804007143SurgiPlast Nasal SplintSurgiPlast - Large - White Color - 1.6mm2024-09-30
00854804007150SurgiPlast Nasal SplintSurgiPlast - Large - White Color - 2.0mm2024-09-30
00854804007167SurgiPlast Nasal SplintSurgiPlast - Small - Skin Color - 1.6mm2024-09-30
00854804007174SurgiPlast Nasal SplintSurgiPlast - Small - Skin Color - 2.0mm2024-09-30
00854804007198SurgiPlast Nasal SplintSurgiPlast - Small - White Color - 1.6mm2024-09-30
00854804007204SurgiPlast Nasal SplintSurgiPlast - Small - White - 2.0mm2024-09-30
00854804007211SurgiPlast Nasal SplintSurgiPlast - Square - Skin Color - 1.6mm2024-09-30
00854804007228SurgiPlast Nasal SplintSurgiPlast - Square - Skin Color - 2.0mm2024-09-30
00854804007235SurgiPlast Nasal SplintSurgiPlast - Square - White Color - 1.6mm2024-09-30
00854804007242SurgiPlast Nasal SplintSurgiPlast - Square - White Color - 2.0mm2024-09-30
00851988007983Saf-T-Vac Smoke and Fluid EvacuatorST9000SST9000S2017-07-06
00854804007068PureForm6PN01*6PN01*2021-08-30
00854804007075PureForm4PN01*4PN01*2021-08-30
00854804007082PureForm5PN01*5PN01*2021-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09321502015615BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502020732BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502021760BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502021777BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
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
00841036204181HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-15
00841036203955HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203962HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203979HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203986HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203849HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-09
00841036203856HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-09
00841036203689HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203771HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203788HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203795HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203801HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203580HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203597HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203603HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
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
00841036203375HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04
00841036203382HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04