G1 40 Radiopaque Bone Cement

GUDID 08058964723970

Radiopaque Bone Cement

G21 SRL

Orthopaedic cement, non-medicated
Primary Device ID08058964723970
NIH Device Record Key3d6b433d-db50-4762-b122-02c84e5c44a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameG1 40 Radiopaque Bone Cement
Version Model Number800002
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
GS108058964723970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LODBone Cement

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-09
Device Publish Date2020-04-01

Devices Manufactured by G21 SRL

08058964727923 - SpaceFlex Acetabular Cup2023-04-19 The SpaceFlex Acetabular Cup consists of disposable cement spacer molds indicated for use to mold a temporary Acetabular cup rep
08058964726339 - Winch Kyphoplasty ( 15 mm) 11 Gauge Balloon Catheter2023-03-06 Kyphoplasty Balloon Catheter
08058964726407 - Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter2023-03-06 Kyphoplasty Balloon Catheter
08058964726742 - FLEX DRILL 13G2022-06-10 Curette with curved distal end used to create a cavity inside the vertebra.
08058964724977 - SpaceFlex Shoulder2021-03-15 Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacemen
08058964726049 - SpaceFlex Shoulder2021-03-15 Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacemen
08058964726056 - SpaceFlex Shoulder2021-03-15 Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacemen
08058964726063 - SpaceFlex Shoulder2021-03-15 Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacemen

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