InterSpace Shoulder Trial

GUDID 08031497002040

InterSpace Shoulder Trial is intended to be used for the selection of the right size of InterSpace Shoulder to be implanted.

TECRES SPA

Shoulder revision prosthesis trial

• Primary Device ID: 08031497002040
• NIH Device Record Key: fda48077-6fa9-4ab3-98b1-60de6366eb90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterSpace Shoulder Trial
• Version Model Number: SPS90Z1
• Company DUNS: 435428396
• Company Name: TECRES SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	08031497002040 [Primary]

FDA Product Code

• HWT: Template

Sterilization

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

[08031497002040]

Moist Heat or Steam Sterilization

[08031497002040]

Moist Heat or Steam Sterilization

[08031497002040]

Moist Heat or Steam Sterilization

[08031497002040]

Moist Heat or Steam Sterilization

[08031497002040]

Moist Heat or Steam Sterilization

[08031497002040]

Moist Heat or Steam Sterilization

[08031497002040]

Moist Heat or Steam Sterilization

[08031497002040]

Moist Heat or Steam Sterilization

[08031497002040]

Moist Heat or Steam Sterilization

[08031497002040]

Moist Heat or Steam Sterilization

[08031497002040]

Moist Heat or Steam Sterilization

[08031497002040]

Moist Heat or Steam Sterilization

[08031497002040]

Moist Heat or Steam Sterilization

[08031497002040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-03
• Device Publish Date: 2022-09-23

Devices Manufactured by TECRES SPA

• 08031497003894 - InterSpace Hip Trial, 46mm Short: 2026-02-19
• 08031497003900 - InterSpace Hip Trial, 54mm Short: 2026-02-19
• 08031497003917 - InterSpace Hip Trial, 60mm Short: 2026-02-19
• 08031497003924 - InterSpace Hip Trial, 46mm Long: 2026-02-19
• 08031497003931 - InterSpace Hip Trial, 54mm Long: 2026-02-19
• 08031497003948 - InterSpace Hip Trial, 60mm Long: 2026-02-19
• 08031497003955 - Interspace GV Hip Spacer 46: 2026-02-19 TAPERED WEDGE STEM
• 08031497003962 - Interspace GV Hip Spacer 54: 2026-02-19 TAPERED WEDGE STEM