FDA.reportPublic FDA data

Technical Products

Primary DI
B051427030
Brand
Technical Products
Company
TECHNICAL PRODUCTS INC
Model
427-03
Device description
silicone oval shape
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
HXAProsthesis, Tendon, Passive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXAProsthesis, Tendon, PassiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973385000OVAL SHAPESTechnical Products, Inc.1997-12-05HXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B051427030PrimaryHIBCC0

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 Diameter3Millimeter

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
03700751502132Universal Tendon SpacerASKORN MEDICALHXA2025-04-20
B051427040Technical ProductsTECHNICAL PRODUCTS INCHXA2016-10-14
B051427050Technical ProductsTECHNICAL PRODUCTS INCHXA2016-10-14
B051427060Technical ProductsTECHNICAL PRODUCTS INCHXA2016-10-14
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00840420121875HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15
00840420121882HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15
00840420132147HUNTERWRIGHT MEDICAL TECHNOLOGY, INC.HXA2015-10-15