MANZA HOLE COVER 104-00-001

GUDID 00841176102422

MANZA M8 SCREW HOLE COVER

STINSON ORTHOPEDICS INC.

Acetabulum prosthesis hole plug

• Primary Device ID: 00841176102422
• NIH Device Record Key: 5dbecd05-f375-4cdf-8923-6a7f93634d83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MANZA HOLE COVER
• Version Model Number: 104-00-001
• Catalog Number: 104-00-001
• Company DUNS: 080460688
• Company Name: STINSON ORTHOPEDICS 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00841176102422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 2016-12-26

On-Brand Devices [MANZA HOLE COVER]

• 00841176102422: MANZA M8 SCREW HOLE COVER
• 00841176102415: MANZA APICAL HOLE COVER