SpaceFlex Hip

GUDID 08058964726902

Disposable custom modular spacer mold

G21 SRL

Orthopaedic cement spacer mould
Primary Device ID08058964726902
NIH Device Record Key44326dfd-1478-4ef1-8309-3b060a1d2a5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpaceFlex Hip
Version Model Number900005 15
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
GS108058964726902 [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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