PEG SMOOTH P28000

GUDID 00887868072314

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00887868072314
• NIH Device Record Key: 95e65d9b-322f-4b13-8be9-a08f633d8a43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEG SMOOTH
• Version Model Number: P28000
• Catalog Number: P28000
• 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
• 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
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• 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
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• Device Size Text, specify: 0
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• 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	00887868072314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050932

FDA Product Code

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

Sterilization

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

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

Moist Heat or Steam Sterilization

[00887868072314]

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 [PEG SMOOTH]

• 00887868011771: 1312-12-230
• 00887868011764: 1312-12-228
• 00887868011757: 1312-12-226
• 00887868011740: 1312-12-224
• 00887868011733: 1312-12-222
• 00887868011726: 1312-12-220
• 00887868011719: 1312-12-218
• 00887868011702: 1312-12-216
• 00887868011696: 1312-12-214
• 00887868011689: 1312-12-212
• 00887868011672: 1312-12-210
• 00887868072321: P30000
• 00887868072314: P28000
• 00887868072307: P26000
• 00887868072291: P24000
• 00887868072284: P22000
• 00887868072277: P20000
• 00887868072260: P18000
• 00887868072253: P16000
• 00887868072246: P14000
• 00887868072239: P12000
• 00887868072178: P10000
• 00887868452420: 1312-12-230
• 00887868452413: 1312-12-228
• 00887868452406: 1312-12-226
• 00887868452390: 1312-12-224
• 00887868452383: 1312-12-222
• 00887868452376: 1312-12-220
• 00887868452369: 1312-12-218
• 00887868452352: 1312-12-216
• 00887868452345: 1312-12-214
• 00887868452338: 1312-12-212
• 00887868452321: 1312-12-210