SYNTEC

GUDID 04719892505109

DRILL GUIDE FOR 2.7 COMPRESSION PLATES

SYNTEC SCIENTIFIC CORPORATION

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04719892505109
• NIH Device Record Key: 42aea004-60fa-4219-b245-34058a9f5e6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNTEC
• Version Model Number: S322210
• Company DUNS: 657692971
• Company Name: SYNTEC SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: true
• 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: 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	04719892505109 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

[04719892505109]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-15
• Device Publish Date: 2024-11-07

Devices Manufactured by SYNTEC SCIENTIFIC CORPORATION

• 04719892505109 - SYNTEC: 2024-11-15DRILL GUIDE FOR 2.7 COMPRESSION PLATES
• 04719892505109 - SYNTEC: 2024-11-15 DRILL GUIDE FOR 2.7 COMPRESSION PLATES
• 04712782854233 - Syntec Osteo-plate and screw Fixation: 2024-02-19 Cortex Screw Self-Tappingφ3.5 x L20mm
• 04712782854257 - Syntec Osteo-plate and screw Fixation: 2024-02-19 Cortex Screw Self-Tappingφ3.5 x L24mm
• 04712782854271 - Syntec Osteo-plate and screw Fixation: 2024-02-19 Cortex Screw Self-Tappingφ3.5 x L28mm
• 04712782854356 - Syntec Osteo-plate and screw Fixation: 2024-02-19 Cortex Screw Self-Tappingφ3.5 x L50mm
• 04712782854363 - Syntec Osteo-plate and screw Fixation: 2024-02-19 Cortex Screw Self-Tappingφ3.5 x L55mm
• 04712782900244 - Syntec Recon Screw: 2024-02-19 Syntec Recon Screw φ6.3 x L115mm
• 04712782900251 - Syntec Recon Screw: 2024-02-19 Syntec Recon Screw φ6.3 x L120mm