Syntec-Taichung Non-sterile Bone Plate and Screw Implants

GUDID 04719864661215

Cortex Screw φ2.0 x 8 mm

SYNTEC SCIENTIFIC CORPORATION

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 04719864661215
• NIH Device Record Key: ab4ddb93-6ed6-49b2-84b0-d764b1f76501
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syntec-Taichung Non-sterile Bone Plate and Screw Implants
• Version Model Number: 211008
• Company DUNS: 657692971
• Company Name: SYNTEC SCIENTIFIC CORPORATION
• 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: 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	04719864661215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983495

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

[04719864661215]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-16

On-Brand Devices [Syntec-Taichung Non-sterile Bone Plate and Screw Implants]

• 04719864661369: Cortex Screw φ2.0 x 38 mm
• 04719864661352: Cortex Screw φ2.0 x 36 mm
• 04719864661345: Cortex Screw φ2.0 x 34 mm
• 04719864661338: Cortex Screw φ2.0 x 32 mm
• 04719864661321: Cortex Screw φ2.0 x 30 mm
• 04719864661314: Cortex Screw φ2.0 x 28 mm
• 04719864661307: Cortex Screw φ2.0 x 26 mm
• 04719864661291: Cortex Screw φ2.0 x 24 mm
• 04719864661284: Cortex Screw φ2.0 x 22 mm
• 04719864661277: Cortex Screw φ2.0 x 20 mm
• 04719864661260: Cortex Screw φ2.0 x 18 mm
• 04719864661253: Cortex Screw φ2.0 x 16 mm
• 04719864661246: Cortex Screw φ2.0 x 14 mm
• 04719864661239: Cortex Screw φ2.0 x 12 mm
• 04719864661222: Cortex Screw φ2.0 x 10 mm
• 04719864661215: Cortex Screw φ2.0 x 8 mm
• 04719864661208: Cortex Screw φ 2.0 x 6 mm
• 04719864684467: L & T-Plate(Left Obliqre) 2.0
• 04719864684672: Straight Reconstruction Plate 3.5x 20Holes x L238mm