InterSpace Shoulder

GUDID 28031497000408

Temporary shoulder spacer with gentamicin. InterSpace Shoulder is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone ce

TECRES SPA

Orthopaedic cement spacer Orthopaedic cement spacer

• Primary Device ID: 28031497000408
• NIH Device Record Key: 74683e15-c853-4713-b305-fe27c8df1731
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterSpace Shoulder
• Version Model Number: SPS0121
• Company DUNS: 435428396
• Company Name: TECRES SPA
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	28031497000408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112983

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

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: 2015-10-08

On-Brand Devices [InterSpace Shoulder]

• 28031497000408: Temporary shoulder spacer with gentamicin. InterSpace Shoulder is composed of fully formed genta
• 28031497000392: Temporary shoulder spacer with gentamicin. InterSpace Shoulder is composed of fully formed genta