SpaceFlex Knee

GUDID 08058964726933

G21 SRL

Orthopaedic cement spacer mould
Primary Device ID08058964726933
NIH Device Record Keyb58eb990-6ed2-41b8-916d-4207fb14fbbe
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpaceFlex Knee
Version Model Number900189 60
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
GS108058964726933 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBBBone Cement, Antibiotic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-09-23
Device Publish Date2019-07-26

On-Brand Devices [SpaceFlex Knee]

08058964726940900189 70
08058964726933900189 60
08058964727039Orthopedic bone cement modular spacer for temporary knee prosthesis

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.