Comprehensive

GUDID 00889024681989

Zimmer, Inc.

Orthopaedic reamer guide

• Primary Device ID: 00889024681989
• NIH Device Record Key: c097c919-afe6-435b-8999-5f5d1a266db9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive
• Version Model Number: 110040242
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024681989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233148

FDA Product Code

• KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-14
• Device Publish Date: 2025-08-06

On-Brand Devices [Comprehensive]

• 00889024518421: SSI002997
• 00887868274800: SSI002143
• 00889024570214: SSI004980
• 00889024569478: SSI003340
• 00889024568686: SSI004821
• 00889024517394: SSI004602
• 00889024517295: SSI003924
• 00889024517271: SSI002508
• 00889024517264: SSI002507
• 00889024516571: SSI003879
• 00889024516564: SSI003878
• 00889024516557: SSI003877
• 00889024516540: SSI003876
• 00889024516533: SSI003314
• 00889024516526: SSI001816
• 00889024682023: 110040484
• 00889024682009: 110040475
• 00889024681989: 110040242
• 00889024681965: 110040240
• 00889024681958: 110040435
• 00889024681941: 110040241
• 00889024681934: 110040239
• 00889024681910: 110040474