InterSpace Knee Trial

GUDID 08031497002347

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

TECRES SPA

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Primary Device ID08031497002347
NIH Device Record Key7045e33d-90c3-4980-a239-163c19a96c0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameInterSpace Knee Trial
Version Model NumberSPK90Z1
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
GS108031497002347 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08031497002347]

Moist Heat or Steam Sterilization


[08031497002347]

Moist Heat or Steam Sterilization


[08031497002347]

Moist Heat or Steam Sterilization


[08031497002347]

Moist Heat or Steam Sterilization


[08031497002347]

Moist Heat or Steam Sterilization


[08031497002347]

Moist Heat or Steam Sterilization


[08031497002347]

Moist Heat or Steam Sterilization


[08031497002347]

Moist Heat or Steam Sterilization


[08031497002347]

Moist Heat or Steam Sterilization


[08031497002347]

Moist Heat or Steam Sterilization


[08031497002347]

Moist Heat or Steam Sterilization


[08031497002347]

Moist Heat or Steam Sterilization


[08031497002347]

Moist Heat or Steam Sterilization


[08031497002347]

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

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