FDA.reportPublic FDA data

NA

Primary DI
10885862209023
Brand
NA
Company
Exactech, Inc.
Model
133-40-14
Catalog number
133-40-14
Device description
TRIAL, LIPPED LINER, 40mm, Group 4, 60/62mm CUP
Published
2022-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862209023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586220902310885862209023

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis trial, prefabricated, reusableA copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter40Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862660527AcuMatch103-61-00103-61-002026-05-28
10885862660541AcuMatch103-61-07103-61-072026-05-28
10885862660558AcuMatch103-61-10103-61-102026-05-28
10885862660565AcuMatch103-61-97103-61-972026-05-28
10885862663207N/A101-14-00101-14-002026-05-28
10885862656117Newton02-521-90-200402-521-90-20042026-05-27
10885862656124Newton02-521-90-200502-521-90-20052026-05-27
10885862656131Newton02-521-90-200602-521-90-20062026-05-27
10885862656148Newton02-521-90-200702-521-90-20072026-05-27
10885862656155Newton02-521-90-200802-521-90-20082026-05-27
10885862656162Newton02-521-90-200902-521-90-20092026-05-27
10885862656179Newton02-521-90-201002-521-90-20102026-05-27
10885862653697Alteon190-00-01190-00-012026-05-26
10885862653703Alteon190-00-02190-00-022026-05-26
10885862653710Alteon190-00-03190-00-032026-05-26
10885862653727Alteon190-00-04190-00-042026-05-26
10885862653734Alteon190-00-05190-00-052026-05-26
10885862653741Alteon190-00-06190-00-062026-05-26
10885862653758Alteon190-00-07190-00-072026-05-26
10885862653765Alteon190-00-08190-00-082026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810022403433LinkBio InstrumentLink Bio CorpHWT2026-06-08
00810022403440LinkBio InstrumentLink Bio CorpHWT2026-06-08
00810022403457LinkBio InstrumentLink Bio CorpHWT2026-06-08
04048844758219EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758233EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758271EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758295EPORE® XOimplantcast GmbHHWT2026-06-02
04048844758776n/aimplantcast GmbHHWT2026-06-02
04048844758820n/aimplantcast GmbHHWT2026-06-02
04048844758950n/aimplantcast GmbHHWT2026-06-02
04048844770747n/aimplantcast GmbHHWT2026-06-02
04048844770808n/aimplantcast GmbHHWT2026-06-02
04048844770891n/aimplantcast GmbHHWT2026-06-02
04048844770938n/aimplantcast GmbHHWT2026-06-02
04048844770952n/aimplantcast GmbHHWT2026-06-02
04048844770976n/aimplantcast GmbHHWT2026-06-02
00850011453544REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCHWT2026-06-01
10603295552680ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555001ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555018ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555025ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555032ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555049ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555056ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555544ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10603295555582ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-05-29
10885862660527AcuMatchExactech, Inc.HWT2026-05-28
10885862660541AcuMatchExactech, Inc.HWT2026-05-28
10885862660558AcuMatchExactech, Inc.HWT2026-05-28
10885862660565AcuMatchExactech, Inc.HWT2026-05-28