Unity Erodium 000E013535

GUDID 00850051372102

Unity Erodium SIJ Screw Ø 13.5 x 35

Dio Medical, Corp.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: 00850051372102
• NIH Device Record Key: 5a66b252-a60f-4168-817e-b69e27df0b48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unity Erodium
• Version Model Number: 000E013535
• Catalog Number: 000E013535
• Company DUNS: 117150006
• Company Name: Dio Medical, Corp.
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850051372102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222448

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

[00850051372102]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-04
• Device Publish Date: 2023-06-26

On-Brand Devices [Unity Erodium]

• 00850051372263: Unity Erodium SIJ Screw Ø 15.0 x 70
• 00850051372256: Unity Erodium SIJ Screw Ø 15.0 x 65
• 00850051372249: Unity Erodium SIJ Screw Ø 15.0 x 60
• 00850051372232: Unity Erodium SIJ Screw Ø 15.0 x 55
• 00850051372225: Unity Erodium SIJ Screw Ø 15.0 x 50
• 00850051372218: Unity Erodium SIJ Screw Ø 15.0 x 45
• 00850051372201: Unity Erodium SIJ Screw Ø 15.0 x 40
• 00850051372195: Unity Erodium SIJ Screw Ø 15.0 x 35
• 00850051372188: Unity Erodium SIJ Screw Ø 15.0 x 30
• 00850051372171: Unity Erodium SIJ Screw Ø 13.5 x 70
• 00850051372164: Unity Erodium SIJ Screw Ø 13.5 x 65
• 00850051372157: Unity Erodium SIJ Screw Ø 13.5 x 60
• 00850051372140: Unity Erodium SIJ Screw Ø 13.5 x 55
• 00850051372133: Unity Erodium SIJ Screw Ø 13.5 x 50
• 00850051372126: Unity Erodium SIJ Screw Ø 13.5 x 45
• 00850051372119: Unity Erodium SIJ Screw Ø 13.5 x 40
• 00850051372102: Unity Erodium SIJ Screw Ø 13.5 x 35
• 00850051372096: Unity Erodium SIJ Screw Ø 13.5 x 30
• 00850051372089: Unity Erodium SIJ Screw Ø 11.5 x 70
• 00850051372072: Unity Erodium SIJ Screw Ø 11.5 x 65
• 00850051372065: Unity Erodium SIJ Screw Ø 11.5 x 60
• 00850051372058: Unity Erodium SIJ Screw Ø 11.5 x 55
• 00850051372041: Unity Erodium SIJ Screw Ø 11.5 x 50
• 00850051372034: Unity Erodium SIJ Screw Ø 11.5 x 45
• 00850051372027: Unity Erodium SIJ Screw Ø 11.5 x 40
• 00850051372010: Unity Erodium SIJ Screw Ø 11.5 x 35
• 00850051372003: Unity Erodium SIJ Screw Ø 11.5 x 30