EPIX Distal Locking Drill 5000-00321

GUDID B2215000003210

Drill Bit

Epix Orthopaedics Inc.

Manual surgical rotary handpiece

• Primary Device ID: B2215000003210
• NIH Device Record Key: 4b46ff95-7c71-405f-ad41-9d8323714f78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIX Distal Locking Drill
• Version Model Number: 5000-00321
• Catalog Number: 5000-00321
• Company DUNS: 084913303
• Company Name: Epix Orthopaedics Inc.
• 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: false
• 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

Customer Support Contacts

• Phone: +1(844)710-9105
• Email: epixortho@icloud.com
• Phone: +1(844)710-9105
• Email: epixortho@icloud.com
• Phone: +1(844)710-9105
• Email: epixortho@icloud.com
• Phone: +1(844)710-9105
• Email: epixortho@icloud.com
• Phone: +1(844)710-9105
• Email: epixortho@icloud.com
• Phone: +1(844)710-9105
• Email: epixortho@icloud.com
• Phone: +1(844)710-9105
• Email: epixortho@icloud.com
• Phone: +1(844)710-9105
• Email: epixortho@icloud.com
• Phone: +1(844)710-9105
• Email: epixortho@icloud.com
• Phone: +1(844)710-9105
• Email: epixortho@icloud.com
• Phone: +1(844)710-9105
• Email: epixortho@icloud.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B2215000003210 [Primary]

FDA Product Code

• HTW: BIT, DRILL

Sterilization

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

[B2215000003210]

Moist Heat or Steam Sterilization

[B2215000003210]

Moist Heat or Steam Sterilization

[B2215000003210]

Moist Heat or Steam Sterilization

[B2215000003210]

Moist Heat or Steam Sterilization

[B2215000003210]

Moist Heat or Steam Sterilization

[B2215000003210]

Moist Heat or Steam Sterilization

[B2215000003210]

Moist Heat or Steam Sterilization

[B2215000003210]

Moist Heat or Steam Sterilization

[B2215000003210]

Moist Heat or Steam Sterilization

[B2215000003210]

Moist Heat or Steam Sterilization

[B2215000003210]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-13
• Device Publish Date: 2019-03-05

On-Brand Devices [EPIX Distal Locking Drill]

• B2215000003210: Drill Bit
• B2215000003200: Drill Bit