RINGLOC MALLORY HEAD HIP SYSTEM 13-104146

GUDID 00880304226838

Biomet Orthopedics, LLC

Metallic femoral head prosthesis

• Primary Device ID: 00880304226838
• NIH Device Record Key: 58823a5d-14ab-40f4-a7c7-90da83bfacd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RINGLOC MALLORY HEAD HIP SYSTEM
• Version Model Number: 13-104146
• Catalog Number: 13-104146
• 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: true
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304226838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030055

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

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 [RINGLOC MALLORY HEAD HIP SYSTEM]

• 00880304227033: 13-104180
• 00880304227026: 13-104178
• 00880304227019: 13-104176
• 00880304227002: 13-104174
• 00880304226999: 13-104172
• 00880304226982: 13-104170
• 00880304226975: 13-104168
• 00880304226968: 13-104166
• 00880304226951: 13-104164
• 00880304226944: 13-104162
• 00880304226937: 13-104160
• 00880304226920: 13-104158
• 00880304226913: 13-104156
• 00880304226890: 13-104154
• 00880304226883: 13-104152
• 00880304226876: 13-104150
• 00880304226852: 13-104148
• 00880304226838: 13-104146
• 00880304226821: 13-104144
• 00880304226814: 13-104142
• 00880304226807: 13-104140
• 00880304226791: 13-104080
• 00880304226784: 13-104078
• 00880304226777: 13-104076
• 00880304226760: 13-104074
• 00880304226753: 13-104072
• 00880304226746: 13-104070
• 00880304226739: 13-104068
• 00880304226722: 13-104066
• 00880304226715: 13-104064
• 00880304226708: 13-104062
• 00880304226692: 13-104060
• 00880304226685: 13-104058
• 00880304226661: 13-104056
• 00880304226647: 13-104054
• 00880304226630: 13-104052
• 00880304226623: 13-104050
• 00880304226609: 13-104048
• 00880304226593: 13-104046
• 00880304226586: 13-104044
• 00880304226579: 13-104042
• 00880304226562: 13-104040
• 00880304219991: 12-104180
• 00880304219984: 12-104178
• 00880304219977: 12-104176
• 00880304219960: 12-104174
• 00880304219953: 12-104172
• 00880304219946: 12-104170
• 00880304219922: 12-104168
• 00880304219915: 12-104166