InterSpace Hip Trial

GUDID 08031497002873

InterSpace Hip Trial is intended to be used for the selection of the right size of InterSpace Hip to be implanted.

TECRES SPA

Hip revision prosthesis trial
Primary Device ID08031497002873
NIH Device Record Key69cd088a-4326-4a30-9e78-e1db96846198
Commercial Distribution StatusIn Commercial Distribution
Brand NameInterSpace Hip Trial
Version Model NumberSPC90Z1
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108031497002873 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08031497002873]

Moist Heat or Steam Sterilization


[08031497002873]

Moist Heat or Steam Sterilization


[08031497002873]

Moist Heat or Steam Sterilization


[08031497002873]

Moist Heat or Steam Sterilization


[08031497002873]

Moist Heat or Steam Sterilization


[08031497002873]

Moist Heat or Steam Sterilization


[08031497002873]

Moist Heat or Steam Sterilization


[08031497002873]

Moist Heat or Steam Sterilization


[08031497002873]

Moist Heat or Steam Sterilization


[08031497002873]

Moist Heat or Steam Sterilization


[08031497002873]

Moist Heat or Steam Sterilization


[08031497002873]

Moist Heat or Steam Sterilization


[08031497002873]

Moist Heat or Steam Sterilization


[08031497002873]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-03
Device Publish Date2022-09-23

Devices Manufactured by TECRES SPA

08031497003894 - InterSpace Hip Trial, 46mm Short2026-02-19
08031497003900 - InterSpace Hip Trial, 54mm Short2026-02-19
08031497003917 - InterSpace Hip Trial, 60mm Short2026-02-19
08031497003924 - InterSpace Hip Trial, 46mm Long 2026-02-19
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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