SpaceFlex Hip

GUDID 08058964726889

Disposable custom modular spacer mold

G21 SRL

Orthopaedic cement spacer mould
Primary Device ID08058964726889
NIH Device Record Key89eb839a-d22b-4536-b697-f9483cfcc3c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpaceFlex Hip
Version Model Number900005 10
Company DUNS431529195
Company NameG21 SRL
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 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
GS108058964726889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWLProsthesis, Hip, Hemi-, Femoral, Metal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-12
Device Publish Date2019-11-04

On-Brand Devices [SpaceFlex Hip]

08058964726902Disposable custom modular spacer mold
08058964726896Disposable custom modular spacer mold
08058964726889Disposable custom modular spacer mold

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