GUN-01

GUDID 08031497002187

GUN-01 is intended to be used for helping the extrusion (and hence the delivery) of bone cement only from the Tecres’ syringes Cemex System Device.

TECRES SPA

Orthopaedic cement/bone filler dispensing gun

• Primary Device ID: 08031497002187
• NIH Device Record Key: 4792e870-5023-4656-9669-be2a5875bbc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GUN-01
• Version Model Number: GUN-01
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08031497002187 [Primary]

FDA Product Code

• KIH: Dispenser, Cement

Sterilization

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

[08031497002187]

Moist Heat or Steam Sterilization

[08031497002187]

Moist Heat or Steam Sterilization

[08031497002187]

Moist Heat or Steam Sterilization

[08031497002187]

Moist Heat or Steam Sterilization

[08031497002187]

Moist Heat or Steam Sterilization

[08031497002187]

Moist Heat or Steam Sterilization

[08031497002187]

Moist Heat or Steam Sterilization

[08031497002187]

Moist Heat or Steam Sterilization

[08031497002187]

Moist Heat or Steam Sterilization

[08031497002187]

Moist Heat or Steam Sterilization

[08031497002187]

Moist Heat or Steam Sterilization

[08031497002187]

Moist Heat or Steam Sterilization

[08031497002187]

Moist Heat or Steam Sterilization

[08031497002187]

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