EIT PLIF Iserter

GUDID 04260557776124

T-Handle Inserter

EIT Emerging Implant Technologies GmbH

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 04260557776124
• NIH Device Record Key: c0fc0efa-a902-4404-ab2f-3838f20ec709
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EIT PLIF Iserter
• Version Model Number: PET30103
• Company DUNS: 313088331
• Company Name: EIT Emerging Implant Technologies GmbH
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04260557776124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170503

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[04260557776124]

Moist Heat or Steam Sterilization

[04260557776124]

Moist Heat or Steam Sterilization

[04260557776124]

Moist Heat or Steam Sterilization

[04260557776124]

Moist Heat or Steam Sterilization

[04260557776124]

Moist Heat or Steam Sterilization

[04260557776124]

Moist Heat or Steam Sterilization

[04260557776124]

Moist Heat or Steam Sterilization

[04260557776124]

Moist Heat or Steam Sterilization

[04260557776124]

Moist Heat or Steam Sterilization

[04260557776124]

Moist Heat or Steam Sterilization

[04260557776124]

Moist Heat or Steam Sterilization

[04260557776124]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-09-21

Devices Manufactured by EIT Emerging Implant Technologies GmbH

• 04260557770009 - EIT CIF cage: 2020-02-24 EIT CIF cage, H 5mm, 0°, S
• 04260557770016 - EIT CIF cage: 2020-02-24 EIT CIF cage, H 5mm, 0°, S
• 04260557770023 - EIT CIF cage: 2020-02-24 EIT CIF cage, H 6mm, 0°, S
• 04260557770030 - EIT CIF cage: 2020-02-24 EIT CIF cage, H 7mm, 0°, S
• 04260557770047 - EIT CIF cage: 2020-02-24 EIT CIF cage, H 8mm, 0°, S
• 04260557770054 - EIT CIF cage: 2020-02-24 EIT CIF cage, H 9mm, 0°, S
• 04260557770061 - EIT CIF cage: 2020-02-24 EIT CIF cage, H 10mm, 0°, S
• 04260557770078 - EIT CIF cage: 2020-02-24 EIT CIF cage, H 11mm, 0°, S