FDA.reportPublic FDA data

Technical Products

Primary DI
B051515070
Brand
Technical Products
Company
TECHNICAL PRODUCTS INC
Model
515-07
Device description
silicone rod
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MIBElastomer, Silicone Block

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIBElastomer, Silicone BlockEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973166000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973166000DOW CORNING SILASTIC ELASTOMER Q7-4750Technical Products, Inc.1997-11-21MIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B051515070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Silicone-sheet tissue reconstructive material, non-sterileA non-sterile, flat stretch of silicone elastomer typically modified to suit the patient anatomy intended to be implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile). It may be cut into different sizes and shapes for various reconstructive or cosmetic plastic surgery applications that include repair of nasal septums, perforated eardrums, herniations, diaphragms, orbital floors, or congenital fissures of the abdominal wall.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter7Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
040679649
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B051EZ0813Technical ProductsEZ-0813EZ-08132024-02-16
B051EZ0815Technical ProductsEZ-0815EZ-08152024-02-16
B051EZ0817Technical ProductsEZ-0817EZ-08172024-02-16
B051EZ0819Technical ProductsEZ-0819EZ-08192024-02-16
B051EZ0821Technical ProductsEZ-0821EZ-08212024-02-16
B051EZ0823Technical ProductsEZ-0823EZ-08232024-02-16
B051EZ1111Technical ProductsEZ-1111EZ-11112024-02-16
B051EZ1113Technical ProductsEZ-1113EZ-11132024-02-16
B051EZ1115Technical ProductsEZ-1115EZ-11152024-02-16
B051EZ1119Technical ProductsEZ-1119EZ-11192024-02-16
B051EZ1122Technical ProductsEZ-1122EZ-11222024-02-16
B051EZ1124Technical ProductsEZ-1124EZ-11242024-02-16
B051EZ1127Technical ProductsEZ-1127EZ-11272024-02-16
B051EZ1130Technical ProductsEZ-1130EZ-11302024-02-16
B051EZ1135Technical ProductsEZ-1135EZ-11352024-02-16
B051EZ1138Technical ProductsEZ-1138EZ-11382024-02-16
B051EZ1311Technical ProductsEZ-1311EZ-13112024-02-16
B051EZ1313Technical ProductsEZ-1313EZ-13132024-02-16
B051EZ1315Technical ProductsEZ-1315EZ-13152024-02-16
B051EZ1319Technical ProductsEZ-1319EZ-13192024-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M724CCB5SIZ7NS1ContourFlex™ Gluteal Implant Sizer RoundIMPLANTECH ASSOCIATES, INC.MIB2024-05-20
M724CCB11SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB12SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB13SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB14SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB15SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB21SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB22SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB23SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB31SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB32SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB33SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB41SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB42SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB43SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB44SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB45SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZK1NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZNC1NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZNC3NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB7SIZ1NS1ContourFlex™ Calf Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB7SIZ3NS1ContourFlex™ Calf Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB50NS1ContourFlex™ Gluteal ImplantIMPLANTECH ASSOCIATES, INC.MIB2017-07-10
M724CCB45NS1Contoured Carving BlockIMPLANTECH ASSOCIATES, INC.MIB2016-04-22
M72423700071AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700101AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700151AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700201AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700301AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700401AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24