Malibu 70-7035

GUDID M5567070351

TSC Uni-Planar Screw 7.0 x 35mm

Seaspine, Inc.

Multiple Rickettsia species (typhus group) immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

• Primary Device ID: M5567070351
• NIH Device Record Key: c847c78d-f222-443e-b491-dd3d63319b52
• Commercial Distribution Discontinuation: 2015-11-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Malibu
• Version Model Number: 70-7035
• Catalog Number: 70-7035
• Company DUNS: 119614407
• Company Name: Seaspine, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780006046 [Primary]
HIBCC	M5567070351 [Secondary]

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M5567070351]

Moist Heat or Steam Sterilization

[M5567070351]

Moist Heat or Steam Sterilization

[M5567070351]

Moist Heat or Steam Sterilization

[M5567070351]

Moist Heat or Steam Sterilization

[M5567070351]

Moist Heat or Steam Sterilization

[M5567070351]

Moist Heat or Steam Sterilization

[M5567070351]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-08-09
• Device Publish Date: 2014-09-22

Devices Manufactured by Seaspine, Inc.

• M5567070351 - Malibu: 2021-08-09TSC Uni-Planar Screw 7.0 x 35mm
• M5567070351 - Malibu: 2021-08-09 TSC Uni-Planar Screw 7.0 x 35mm
• 10889981028107 - Coral: 2018-07-06 CORAL® DEFORMITY IMPLANTS 1. The Coral Spinal System consists of a variety of types and sizes of rods, hooks, screws, and conne