Dual Top Screw System

GUDID 08800089426652

Jeil Medical Corporation

Orthodontic anchoring screw

• Primary Device ID: 08800089426652
• NIH Device Record Key: 63884705-fe29-44df-8858-f7b2937c06c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dual Top Screw System
• Version Model Number: 13-JO-005
• Company DUNS: 688811603
• Company Name: Jeil Medical 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	08800089426652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161335

FDA Product Code

• OAT: Implant, Endosseous, Orthodontic

Sterilization

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

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

[08800089426652]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-19
• Device Publish Date: 2022-01-11

On-Brand Devices [Dual Top Screw System]

• 08806390899833: S13-JK-006
• 08806390891622: S20-JK-008
• 08806390880473: S13-JO-008
• 08806390876926: S13-JK-008
• 08800089427130: S20-JO-012
• 08800089427123: S20-JO-010
• 08800089427116: S20-JO-008
• 08800089427109: S20-JO-007
• 08800089427093: S20-JO-006
• 08800089427086: S20-JO-005
• 08800089427079: S20-JK-012
• 08800089427062: S20-JK-007
• 08800089427055: S16-MIM-007
• 08800089427048: S16-JO-012
• 08800089427031: S16-JO-007
• 08800089427024: S16-JO-005
• 08800089427017: S16-JK-012
• 08800089427000: S16-JK-007
• 08800089426997: S14-MIM-007
• 08800089426980: S14-JO-012
• 08800089426973: S14-JO-010
• 08800089426966: S14-JO-008
• 08800089426959: S14-JO-007
• 08800089426942: S14-JO-006
• 08800089426935: S14-JO-005
• 08800089426928: S14-JK-012
• 08800089426911: S14-JK-007
• 08800089426904: S14-JK-005
• 08800089426898: S13-JO-007
• 08800089426881: S13-JO-006
• 08800089426874: S13-JO-005
• 08800089426867: S13-JK-007
• 08800089426850: S13-JK-005
• 08800089426843: 20-JO-012
• 08800089426836: 20-JO-007
• 08800089426829: 20-JK-012
• 08800089426812: 20-JK-007
• 08800089426805: 16-MIM-007
• 08800089426799: 16-JO-012
• 08800089426782: 16-JO-007
• 08800089426775: 16-JK-012
• 08800089426768: 16-JK-007
• 08800089426751: 14-MIM-007
• 08800089426744: 14-JO-012
• 08800089426737: 14-JO-010
• 08800089426720: 14-JO-007
• 08800089426713: 14-JO-005
• 08800089426706: 14-JK-012
• 08800089426690: 14-JK-010
• 08800089426683: 14-JK-007