G21 SRL

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Bone Cement, Antibiotic (MBB) (6) Bone Cement (LOD) (5) Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (5) Cement, Bone, Vertebroplasty (NDN) (2)

Premarket Exempt

No Yes

Clear

G3 40 Radiopaque Bone Cement - 08058964720047 Catalog Number :

Device Description : Radiopaque Bone Cement

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : LOD

Prescription Use : No

Device Count : 1

G3A 40 Bone Cement - 08058964720122 Catalog Number :

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : MBB, LOD

Prescription Use : Yes

Device Count : 1

V-FAST - 08058964720245 Catalog Number : 800036

Device Description : Radiopaque Bone Cement for vertebral consolidation

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : LOD, NDN

Prescription Use : Yes

Device Count : 1

V-STEADY - 08058964723819 Catalog Number : 800039

Device Description : Radiopaque Bone Cement for vertebral consolidation

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : NDN, LOD

Prescription Use : Yes

Device Count : 1

G1 40 Radiopaque Bone Cement - 08058964723970 Catalog Number :

Device Description : Radiopaque Bone Cement

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : LOD

Prescription Use : No

Device Count : 1

SpaceFlex Shoulder - 08058964724977 Catalog Number :

Device Description : Disposable cement spacer molds with metal reinforcement stem are indicated for u

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : MBB, KWS

Prescription Use : Yes

Device Count : 1

SpaceFlex Shoulder - 08058964726049 Catalog Number :

Device Description : Disposable cement spacer molds with metal reinforcement stem are indicated for u

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : MBB, KWS

Prescription Use : Yes

Device Count : 1

SpaceFlex Shoulder - 08058964726056 Catalog Number :

Device Description : Disposable cement spacer molds with metal reinforcement stem are indicated for u

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : MBB, KWS

Prescription Use : Yes

Device Count : 1

SpaceFlex Shoulder - 08058964726063 Catalog Number :

Device Description : Disposable cement spacer molds with metal reinforcement stem are indicated for u

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : MBB, KWS

Prescription Use : Yes

Device Count : 1

SpaceFlex Shoulder - 08058964726070 Catalog Number :

Device Description : Disposable cement spacer molds with metal reinforcement stem are indicated for u

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : MBB, KWS

Prescription Use : Yes

Device Count : 1

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