Eden Spine Europe SA

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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

Orthopedic Manual Surgical Instrument (LXH) (9) Spinal Vertebral Body Replacement Device (MQP) (1)

Premarket Exempt

No Yes

Clear

GIZA - 07640167930111 Catalog Number : 48293125

Device Description : Orthopaedic manual surgical instrument.

Device Class : 1

Duns Number: 482797425

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

GIZA - 07640167930128 Catalog Number : 48293132

Device Description : Orthopaedic manual surgical instrument.

Device Class : 1

Duns Number: 482797425

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

GIZA - 07640167930135 Catalog Number : 48293402

Device Description : Orthopaedic manual surgical instrument.

Device Class : 1

Duns Number: 482797425

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

GIZA - 07640167930142 Catalog Number : 48293403

Device Description : Orthopaedic manual surgical instrument.

Device Class : 1

Duns Number: 482797425

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

GIZA - 07640167930159 Catalog Number : 48293404

Device Description : Orthopaedic manual surgical instrument.

Device Class : 1

Duns Number: 482797425

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

GIZA - 07640167930166 Catalog Number : 48293405

Device Description : Orthopaedic manual surgical instrument.

Device Class : 1

Duns Number: 482797425

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

GIZA - 07640167930173 Catalog Number : 48293406

Device Description : Orthopaedic manual surgical instrument.

Device Class : 1

Duns Number: 482797425

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

GIZA - 07640167930180 Catalog Number : 48293401

Device Description : Orthopaedic manual surgical instrument.

Device Class : 1

Duns Number: 482797425

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

GIZA - 07640167930197 Catalog Number : 48293400

Device Description : Orthopaedic manual surgical instrument.

Device Class : 1

Duns Number: 482797425

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

GIZA - 07640167930265 Catalog Number : GT102000S

Device Description : The GIZA is a spinal vertebral body replacement device.

Device Class : 2

Duns Number: 482797425

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

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