Unity Erodium 000E011570

GUDID 00850051372089

Unity Erodium SIJ Screw Ø 11.5 x 70

Dio Medical, Corp.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: 00850051372089
• NIH Device Record Key: e1d7087a-7f84-4a73-bdaa-53454e51750e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unity Erodium
• Version Model Number: 000E011570
• Catalog Number: 000E011570
• 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	00850051372089 [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

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

Moist Heat or Steam Sterilization

[00850051372089]

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

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