SMOOTH PEG 131227030

GUDID 00880304532854

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00880304532854
• NIH Device Record Key: a9cacdda-2ad1-4e3c-9d02-7c3861deed32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMOOTH PEG
• Version Model Number: 1312-27-030
• Catalog Number: 131227030
• 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: true
• 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(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
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304532854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112345

FDA Product Code

• LXT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Sterilization

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

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

[00880304532854]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [SMOOTH PEG]

• 00880304532854: 1312-27-030
• 00880304532847: 1312-27-028
• 00880304532830: 1312-27-026
• 00880304532823: 1312-27-024
• 00880304532816: 1312-27-022
• 00880304532809: 1312-27-020
• 00880304532793: 1312-27-018
• 00880304532786: 1312-27-016
• 00880304532779: 1312-27-015
• 00880304532762: 1312-27-014
• 00880304532755: 1312-27-013
• 00880304532748: 1312-27-012
• 00880304532731: 1312-27-011
• 00880304532724: 1312-27-010
• 00880304532717: 1312-27-009
• 00880304532700: 1312-27-008
• 00887868545986: P30000
• 00887868545979: P28000
• 00887868545962: P26000
• 00887868545955: P24000
• 00887868545948: P22000
• 00887868545931: P20000
• 00887868545924: P18000
• 00887868545917: P16000
• 00887868545900: P14000
• 00887868545894: P12000
• 00887868545887: P10000
• 00887868544842: 131227030
• 00887868544835: 131227028
• 00887868544828: 131227026
• 00887868544811: 131227024
• 00887868544804: 131227022
• 00887868544798: 131227020
• 00887868544781: 131227018
• 00887868544774: 131227016
• 00887868544767: 131227015
• 00887868544750: 131227014
• 00887868544743: 131227013
• 00887868544736: 131227012
• 00887868544729: 131227011
• 00887868544712: 131227010
• 00887868544705: 131227009
• 00887868544699: 131227008