MectaCem Bowl

GUDID 08031497002859

TECRES SPA

Orthopaedic cement mixing bowl
Primary Device ID08031497002859
NIH Device Record Key2320d38b-33f6-40a0-9eb1-8043fab6bdef
Commercial Distribution StatusIn Commercial Distribution
Brand NameMectaCem Bowl
Version Model Number20.00004
Company DUNS435428396
Company NameTECRES SPA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108031497002859 [Primary]

FDA Product Code

JDZMixer, Cement, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-25
Device Publish Date2022-11-17

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08031497003931 - InterSpace Hip Trial, 54mm Long2026-02-19
08031497003948 - InterSpace Hip Trial, 60mm Long2026-02-19
08031497003955 - Interspace GV Hip Spacer 462026-02-19 TAPERED WEDGE STEM
08031497003962 - Interspace GV Hip Spacer 542026-02-19 TAPERED WEDGE STEM

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