Acumatch P Series 114-01-03

GUDID 10885862017482

Exactech, Inc.

Press-fit femoral stem prosthesis
Primary Device ID10885862017482
NIH Device Record Keydf264a94-f625-4c0c-9264-960a823c138d
Commercial Distribution Discontinuation2024-06-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAcumatch P Series
Version Model Number114-01-03
Catalog Number114-01-03
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

Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter
Device Size Text, specify0
Length145 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862017482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

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 Date2015-08-10

On-Brand Devices [Acumatch P Series]

10885862019486118-41-07
10885862019479118-41-06
10885862019462118-41-05
10885862019455118-41-04
10885862019431118-41-02
10885862019424118-41-01
10885862019417118-41-00
10885862019400118-40-07
10885862019394118-40-06
10885862019387118-40-05
10885862019370118-40-04
10885862019363118-40-03
10885862019356118-40-02
10885862019349118-40-01
10885862019332118-40-00
10885862018939118-01-07
10885862018922118-01-06
10885862018915118-01-05
10885862018908118-01-04
10885862018892118-01-03
10885862018885118-01-02
10885862018878118-01-01
10885862018861118-01-00
10885862018809118-00-02
10885862018793118-00-01
10885862018786118-00-00
10885862017512114-01-06
10885862017505114-01-05
10885862017499114-01-04
10885862017482114-01-03
10885862017475114-01-02
10885862017468114-01-01
10885862017451114-01-00

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