IMPIX-ALIF S/A

GUDID 03613720236122

IMPIX-ALIF S/A SCREW Lg:26mm Ø4.5

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 03613720236122
• NIH Device Record Key: d181b8ee-110a-440e-bed0-ddc88b25ecc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPIX-ALIF S/A
• Version Model Number: B15274526
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	03613720236122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141187

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

[03613720236122]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-05-23
• Device Publish Date: 2017-01-27

On-Brand Devices [IMPIX-ALIF S/A]

• 03613720266860: DETACHABLE HOLDER
• 03613720266853: STRAIGHT SCREW REMOVER
• 03613720228202: IMPIX-ALIF S/A Medium 14mm x 12°
• 03613720228196: IMPIX-ALIF S/A Medium 14mm x 9°
• 03613720228189: IMPIX-ALIF S/A Medium 12mm x 12°
• 03613720228172: IMPIX-ALIF S/A Medium 12mm x 9°
• 03613720228165: IMPIX-ALIF S/A Medium 10mm x 15°
• 03613720228158: IMPIX-ALIF S/A Medium 10mm x 12°
• 03613720228141: IMPIX-ALIF S/A Medium 10mm x 9°
• 03613720228073: IMPIX-ALIF S/A Small 14mm x 12°
• 03613720228066: IMPIX-ALIF S/A Small 14mm x 9°
• 03613720228059: IMPIX-ALIF S/A Small 12mm x 12°
• 03613720228042: IMPIX-ALIF S/A Small 12mm x 9°
• 03613720228035: IMPIX-ALIF S/A Small 10mm x 15° °
• 03613720228028: IMPIX-ALIF S/A Small 10mm x 12°
• 03613720228011: IMPIX-ALIF S/A Small 10mm x 9°
• 03613720219187: IMPIX ALIF S/A TRIAL MEDIUM 20mm - 15°
• 03613720219170: IMPIX ALIF S/A TRIAL MEDIUM 20mm - 12°
• 03613720219163: IMPIX ALIF S/A TRIAL MEDIUM 20mm - 9°
• 03613720219156: IMPIX ALIF S/A TRIAL MEDIUM 20mm - 6°
• 03613720219149: IMPIX ALIF S/A TRIAL MEDIUM 20mm -3°
• 03613720219132: IMPIX ALIF S/A TRIAL MEDIUM 20mm - 0°
• 03613720219125: IMPIX ALIF S/A TRIAL MEDIUM 18mm - 15°
• 03613720219118: IMPIX ALIF S/A TRIAL MEDIUM 18mm - 12°
• 03613720219101: IMPIX ALIF S/A TRIAL MEDIUM 18mm - 9°
• 03613720219095: IMPIX ALIF S/A TRIAL MEDIUM 18mm - 6°
• 03613720219088: IMPIX ALIF S/A TRIAL MEDIUM 18mm -3°
• 03613720219071: IMPIX ALIF S/A TRIAL MEDIUM 18mm - 0°
• 03613720219064: IMPIX ALIF S/A TRIAL MEDIUM 16mm -15°
• 03613720219057: IMPIX ALIF S/A TRIAL MEDIUM 16mm - 12°
• 03613720219040: IMPIX ALIF S/A TRIAL MEDIUM 16mm - 9°
• 03613720219033: IMPIX ALIF S/A TRIAL MEDIUM 16mm - 6°
• 03613720219026: IMPIX ALIF S/A TRIAL MEDIUM 16mm -3°
• 03613720219019: IMPIX ALIF S/A TRIAL MEDIUM 16mm - 0°
• 03613720218975: IMPIX ALIF S/A TRIAL MEDIUM 14mm - 6°
• 03613720218968: IMPIX ALIF S/A TRIAL MEDIUM 40mm -3°
• 03613720218944: IMPIX ALIF S/A TRIAL MEDIUM 12mm -15°
• 03613720218937: IMPIX ALIF S/A TRIAL MEDIUM 12mm - 12°
• 03613720218920: IMPIX ALIF S/A TRIAL MEDIUM 12mm - 9°
• 03613720270911: INSTRUMENTS FOR ALIF S/A TRAY 2
• 03613720218883: IMPIX ALIF S/A TRIAL MEDIUM 10mm -15°
• 03613720218777: IMPIX ALIF S/A TRIAL LARGE 20mm - 3°
• 03613720218630: IMPIX ALIF S/A TRIAL LARGE 14mm - 15°
• 03613720218005: IMPIX ALIF S/A TRIAL SMALL 18mm - 3°
• 03613720217985: IMPIX-ALIF S/A TRIAL SMALL 16mm x 15°
• 03613720217855: IMPIX ALIF S/A TRIAL SMALL 12mm - 12°
• 03613720217565: IMPIX ALIF S/A RASP SMALL
• 03613720240921: IMPACTION SOCKET -LARGE- 16 to 20 mm WITHOUT END STOP
• 03613720240884: IMPACTION SOCKET -SMALL- 16 to 20 mm WITHOUT END STOP
• 03613720217671: SELF RETAINING SCREWDRIVER WITH STOP