ALLTHREAD(TM) ANCHOR AWL 905955

GUDID 00880304464377

Biomet Orthopedics, LLC

Bone awl Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable

• Primary Device ID: 00880304464377
• NIH Device Record Key: ed7d63db-491a-4c3f-94bc-cb77925585e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALLTHREAD(TM) ANCHOR AWL
• Version Model Number: 905955
• Catalog Number: 905955
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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

Customer Support Contacts

• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304464377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193402

FDA Product Code

• HWC: Screw, fixation, bone
• HWP: PUNCH, FEMORAL NECK

Sterilization

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

[00880304464377]

Moist Heat or Steam Sterilization

[00880304464377]

Moist Heat or Steam Sterilization

[00880304464377]

Moist Heat or Steam Sterilization

[00880304464377]

Moist Heat or Steam Sterilization

[00880304464377]

Moist Heat or Steam Sterilization

[00880304464377]

Moist Heat or Steam Sterilization

[00880304464377]

Moist Heat or Steam Sterilization

[00880304464377]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-04-23
• Device Publish Date: 2017-07-28

Devices Manufactured by Biomet Orthopedics, LLC

• 00887868004087 - PRIMARY TREPHINE: 2024-04-03
• 00887868004094 - BUSHING: 2024-04-03
• 00887868004100 - SECONDARY TREPHINE: 2024-04-03
• 00887868048272 - TREPHINE: 2024-04-03
• 00887868048289 - TREPHINE: 2024-04-03
• 00887868048296 - TREPHINE: 2024-04-03
• 00887868048302 - TREPHINE: 2024-04-03
• 00880304658387 - Compress®: 2024-03-11