Reusable 5mm Pro Shim

GUDID 05065012584257

5mm Spacer for Patella Assessment.

EVENTUM ORTHOPAEDICS LTD

Orthopaedic fixation implant alignment tool
Primary Device ID05065012584257
NIH Device Record Keyd8587b91-14c3-4fb6-82b9-fa5349169e34
Commercial Distribution StatusIn Commercial Distribution
Brand NameReusable 5mm Pro Shim
Version Model NumberRS500
Company DUNS226230358
Company NameEVENTUM ORTHOPAEDICS LTD
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+442045428754
Emailregulatory@eventumortho.com
Phone+442045428754
Emailregulatory@eventumortho.com
Phone+442045428754
Emailregulatory@eventumortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105065012584257 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05065012584257]

Moist Heat or Steam Sterilization


[05065012584257]

Moist Heat or Steam Sterilization


[05065012584257]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-13
Device Publish Date2026-02-05

Devices Manufactured by EVENTUM ORTHOPAEDICS LTD

05065012584257 - Reusable 5mm Pro Shim2026-02-135mm Spacer for Patella Assessment.
05065012584257 - Reusable 5mm Pro Shim2026-02-13 5mm Spacer for Patella Assessment.
05065012584264 - Reusable 5mm 2.5 degree Pro shim2026-02-13 5mm, 2.5 Degree, Spacer for Patella Assessment.
05065012584271 - Reusable 6mm Pro shim2026-02-13 6mm Spacer for Patella Assessment.
05065012584288 - Reusable 6mm 2.5 degree Pro shim2026-02-13 6mm, 2.5 Degree, Spacer for Patella Assessment.
05065012584295 - Reusable 7mm Pro shim2026-02-13 7mm Spacer for Patella Assessment.
05065012584301 - Reusable 7mm 2.5 degree Pro shim2026-02-13 7mm, 2.5 Degree, Spacer for Patella Assessment.
05065012584318 - Reusable 8mm Pro shim2026-02-13 8mm Spacer for Patella Assessment.
05065012584325 - Reusable 8mm 2.5 degree Pro shim2026-02-13 8mm, 2.5 Degree, Spacer for Patella Assessment.

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