4CIS SARA SPINE SYSTEM 1020-7765

GUDID 00840185303233

Mono-axial Reduction Pedicle Screw, Ø7.5 mm, 65 mm Length

SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840185303233
• NIH Device Record Key: c75e3737-0a60-4b9a-8d97-99f1e4277b1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4CIS SARA SPINE SYSTEM
• Version Model Number: AISP-1020-7565
• Catalog Number: 1020-7765
• Company DUNS: 868354728
• Company Name: SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
• Device Count: 1
• DM Exempt: true
• 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	00840185303233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202498

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

[00840185303233]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-05
• Device Publish Date: 2021-03-26

On-Brand Devices [4CIS SARA SPINE SYSTEM]

• 00840185314598: Poly-axial Reduction Pedicle Screw, Ø7.5 mm , 100 mm Length
• 00840185314581: Poly-axial Reduction Pedicle Screw, Ø7.5 mm , 95 mm Length
• 00840185314574: Poly-axial Reduction Pedicle Screw, Ø7.5 mm , 90 mm Length
• 00840185314567: Poly-axial Reduction Pedicle Screw, Ø7.5 mm , 85 mm Length
• 00840185314550: Poly-axial Reduction Pedicle Screw, Ø7.5 mm , 80 mm Length
• 00840185314543: Poly-axial Reduction Pedicle Screw, Ø7.0 mm , 100 mm Length
• 00840185314536: Poly-axial Reduction Pedicle Screw, Ø7.0 mm , 95 mm Length
• 00840185314529: Poly-axial Reduction Pedicle Screw, Ø7.0 mm , 90 mm Length
• 00840185314512: Poly-axial Reduction Pedicle Screw, Ø7.0 mm , 85 mm Length
• 00840185314505: Poly-axial Reduction Pedicle Screw, Ø7.0 mm , 80 mm Length
• 00840185314499: Poly-axial Reduction Pedicle Screw, Ø6.5 mm , 100 mm Length
• 00840185314482: Poly-axial Reduction Pedicle Screw, Ø6.5 mm , 95 mm Length
• 00840185314475: Poly-axial Reduction Pedicle Screw, Ø6.5 mm , 90 mm Length
• 00840185314468: Poly-axial Reduction Pedicle Screw, Ø6.5 mm , 85 mm Length
• 00840185314451: Poly-axial Reduction Pedicle Screw, Ø6.5 mm , 80 mm Length
• 00840185311085: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 100
• 00840185311078: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 95
• 00840185311061: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 90
• 00840185311054: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 85
• 00840185311047: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 80
• 00840185311030: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 75
• 00840185311023: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 70
• 00840185311016: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 65
• 00840185311009: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 60
• 00840185310996: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 55
• 00840185310989: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 50
• 00840185310972: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 45
• 00840185310965: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 40
• 00840185310958: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 35
• 00840185310927: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 100
• 00840185310910: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 95
• 00840185310903: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 90
• 00840185310897: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 85
• 00840185310880: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 80
• 00840185310873: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 75
• 00840185310866: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 70
• 00840185310859: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 65
• 00840185310842: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 60
• 00840185310835: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 55
• 00840185310828: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 50
• 00840185310811: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 45
• 00840185310804: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 40
• 00840185310798: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 35
• 00840185310767: Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, Length mm : 100
• 00840185310750: Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, Length mm : 95
• 00840185310743: Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, Length mm : 90
• 00840185310736: Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, Length mm : 85
• 00840185310729: Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, Length mm : 80
• 00840185310712: Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, Length mm : 75
• 00840185310705: Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 70 mm Length