EIT PLIF Distractor

GUDID 04260397088012

Parallel Distractors, H 8mm

EIT Emerging Implant Technologies GmbH

Orthopaedic surgical distractor, internal

• Primary Device ID: 04260397088012
• NIH Device Record Key: 2f1dd396-8b02-4b20-8069-a15a91b49d88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EIT PLIF Distractor
• Version Model Number: PET10821
• 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	04260397088012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170503

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[04260397088012]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-12-11
• Device Publish Date: 2018-09-21

On-Brand Devices [EIT PLIF Distractor]

• 04260557776100: Lordotic Trial Distractor, H 16mm, 18°, 26/6
• 04260557776094: Lordotic Trial Distractor, H 15mm, 18°, 26/6
• 04260557776087: Lordotic Trial Distractor, H 14mm, 18°, 26/6
• 04260557776070: Lordotic Trial Distractor, H 13mm, 18°, 22/6
• 04260557776063: Lordotic Trial Distractor, H 12mm, 18°, 22/6
• 04260557776056: Lordotic Trial Distractor, H 11mm, 18°, 22/6
• 04260557776049: Lordotic Trial Distractor, H 10mm, 18°, 22/6
• 04260557776032: Lordotic Trial Distractor, H 16mm, 12°, 22/6
• 04260557776025: Lordotic Trial Distractor, H 15mm, 12°, 22/6
• 04260557776018: Lordotic Trial Distractor, H 14mm, 12°, 22/6
• 04260557776001: Lordotic Trial Distractor, H 13mm, 12°, 22/6
• 04260557775998: Lordotic Trial Distractor, H 12mm, 12°, 22/6
• 04260557775981: Lordotic Trial Distractor, H 11mm, 12°, 22/6
• 04260557775974: Lordotic Trial Distractor, H 10mm, 12°, 22/6
• 04260557775967: Lordotic Trial Distractor, H 9mm, 12°, 22/6
• 04260557775950: Lordotic Trial Distractor, H 16mm, 6°, 22/6
• 04260557775943: Lordotic Trial Distractor, H 15mm, 6°, 22/6
• 04260557775936: Lordotic Trial Distractor, H 14mm, 6°, 22/6
• 04260557775929: Lordotic Trial Distractor, H 13mm, 6°, 22/6
• 04260557775912: Lordotic Trial Distractor, H 12mm, 6°, 22/6
• 04260557775905: Lordotic Trial Distractor, H 11mm, 6°, 22/6
• 04260557775899: Lordotic Trial Distractor, H 10mm, 6°, 22/6
• 04260557775882: Lordotic Trial Distractor, H 9mm, 6°, 22/6
• 04260557775875: Lordotic Trial Distractor, H 8mm, 6°, 22/6
• 04260397089057: Lordotic Trial Distractor, H 16mm, 18°, 30/6
• 04260397089040: Lordotic Trial Distractor, H 16mm, 18°, 26/6
• 04260397089033: Lordotic Trial Distractor, H 15mm, 18°, 30/6
• 04260397089026: Lordotic Trial Distractor, H 15mm, 18°, 26/6
• 04260397089019: Lordotic Trial Distractor, H 14mm, 18°, 30/6
• 04260397089002: Lordotic Trial Distractor, H 14mm, 18°, 26/6
• 04260397088999: Lordotic Trial Distractor, H 13mm, 18°, 30/6
• 04260397088982: Lordotic Trial Distractor, H 13mm, 18°, 26/6
• 04260397088975: Lordotic Trial Distractor, H 12mm, 18°, 30/6
• 04260397088968: Lordotic Trial Distractor, H 12mm, 18°, 26/6
• 04260397088951: Lordotic Trial Distractor, H 11mm, 18°, 30/6
• 04260397088944: Lordotic Trial Distractor, H 11mm, 18°, 26/6
• 04260397088937: Lordotic Trial Distractor, H 10mm, 18°, 30/6
• 04260397088920: Lordotic Trial Distractor, H 10mm, 18°, 26/6
• 04260397088913: Lordotic Trial Distractor, H 16mm, 12°, 30/6
• 04260397088906: Lordotic Trial Distractor, H 16mm, 12°, 26/6
• 04260397088890: Lordotic Trial Distractor, H 15mm, 12°, 30/6
• 04260397088876: Lordotic Trial Distractor, H 14mm, 12°, 30/6
• 04260397088869: Lordotic Trial Distractor, H 14mm, 12°, 26/6
• 04260397088852: Lordotic Trial Distractor, H 13mm, 12°, 30/6
• 04260397088845: Lordotic Trial Distractor, H 13mm, 12°, 26/6
• 04260397088838: Lordotic Trial Distractor, H 12mm, 12°, 30/6
• 04260397088821: Lordotic Trial Distractor, H 12mm, 12°, 26/6
• 04260397088814: Lordotic Trial Distractor, H 11mm, 12°, 30/6
• 04260397088807: Lordotic Trial Distractor, H 11mm, 12°, 26/6
• 04260397088791: Lordotic Trial Distractor, H 10mm, 12°, 30/6