WASHERLOC 908437

GUDID 00880304410114

Biomet Orthopedics, LLC

Surgical drill guide, reusable

• Primary Device ID: 00880304410114
• NIH Device Record Key: 95648b40-4a71-496a-80b5-387506a31622
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WASHERLOC
• Version Model Number: 908437
• Catalog Number: 908437
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304410114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122437

FDA Product Code

• FZX: Guide, surgical, instrument
• HWC: Screw, fixation, bone

Sterilization

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

[00880304410114]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-19
• Device Publish Date: 2019-06-11

On-Brand Devices [WASHERLOC]

• 00880304411203: 908860
• 00880304411197: 908858
• 00880304411180: 908856
• 00880304411173: 908854
• 00880304411166: 908852
• 00880304411159: 908850
• 00880304411142: 908848
• 00880304411135: 908846
• 00880304411128: 908844
• 00880304411111: 908842
• 00880304411104: 908840
• 00880304411098: 908838
• 00880304411081: 908836
• 00880304411074: 908834
• 00880304411067: 908832
• 00880304411043: 908830
• 00880304411036: 908828
• 00880304411029: 908826
• 00880304411012: 908824
• 00880304410848: 908660
• 00880304410824: 908658
• 00880304410800: 908656
• 00880304410787: 908654
• 00880304410763: 908652
• 00880304410749: 908650
• 00880304410732: 908648
• 00880304410725: 908646
• 00880304410718: 908644
• 00880304410695: 908642
• 00880304410671: 908640
• 00880304410657: 908638
• 00880304410633: 908636
• 00880304410619: 908634
• 00880304410596: 908632
• 00880304410589: 908630
• 00880304410145: 908439
• 00880304410121: 908438
• 00880304410091: 908436
• 00880304410053: 908433
• 00880304409996: 908427
• 00880304410114: 908437
• 00880304409989: 908426