MCS 146-01-68

GUDID 10885862027696

Exactech, Inc.

Constrained polyethylene acetabular liner
Primary Device ID10885862027696
NIH Device Record Key4a4a7c2a-1ee2-4194-a7aa-222a03675b0c
Commercial Distribution Discontinuation2024-06-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMCS
Version Model Number146-01-68
Catalog Number146-01-68
Company DUNS157565946
Company NameExactech, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862027696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-08-28
Device Publish Date2015-10-30

On-Brand Devices [MCS]


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