G7 OSSEOTI ACETABULAR SHELL 110010276

GUDID 00880304544512

Biomet Orthopedics, LLC

Acetabular shell

• Primary Device ID: 00880304544512
• NIH Device Record Key: 8b6dfffe-e668-487e-b94b-af0e86739b84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G7 OSSEOTI ACETABULAR SHELL
• Version Model Number: 110010276
• Catalog Number: 110010276
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304544512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140669

FDA Product Code

• OQI: Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, 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: 2015-11-02

On-Brand Devices [G7 OSSEOTI ACETABULAR SHELL]

• 00880304544536: 110010278
• 00880304544529: 110010277
• 00880304544512: 110010276
• 00880304544505: 110010275
• 00880304544499: 110010274
• 00880304544482: 110010273
• 00880304544475: 110010272
• 00880304544468: 110010271
• 00880304544451: 110010270
• 00880304544444: 110010269
• 00880304544437: 110010268
• 00880304544420: 110010267
• 00880304544413: 110010266
• 00880304544406: 110010265
• 00880304544390: 110010264
• 00880304544383: 110010263
• 00880304544376: 110010262
• 00880304544369: 110010261
• 00880304544352: 110010260
• 00880304544345: 110010259
• 00880304544277: 110010252
• 00880304544260: 110010251
• 00880304544253: 110010250
• 00880304544246: 110010249
• 00880304544239: 110010248
• 00880304544222: 110010247
• 00880304544215: 110010246
• 00880304544208: 110010245
• 00880304544192: 110010244
• 00880304544185: 110010243
• 00880304544178: 110010242
• 00880304544161: 110010241
• 00880304544154: 110010240
• 00880304544147: 110010239
• 00880304544338: 110010258
• 00880304544321: 110010257
• 00880304544314: 110010256
• 00880304544307: 110010255
• 00880304544291: 110010254
• 00880304544284: 110010253