Leforte System Bone Screw

GUDID 08806390803694

Jeil Medical Corporation

Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable

• Primary Device ID: 08806390803694
• NIH Device Record Key: 4e62362a-ebb7-4e80-9d05-fead4f4f0dd7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leforte System Bone Screw
• Version Model Number: 241.012009
• 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	08806390803694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150965

FDA Product Code

• JEY: Plate, Bone

Sterilization

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

[08806390803694]

Moist Heat or Steam Sterilization

[08806390803694]

Moist Heat or Steam Sterilization

[08806390803694]

Moist Heat or Steam Sterilization

[08806390803694]

Moist Heat or Steam Sterilization

[08806390803694]

Moist Heat or Steam Sterilization

[08806390803694]

Moist Heat or Steam Sterilization

[08806390803694]

Moist Heat or Steam Sterilization

[08806390803694]

Moist Heat or Steam Sterilization

[08806390803694]

Moist Heat or Steam Sterilization

[08806390803694]

Moist Heat or Steam Sterilization

[08806390803694]

Moist Heat or Steam Sterilization

[08806390803694]

Moist Heat or Steam Sterilization

[08806390803694]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-09-18
• Device Publish Date: 2015-11-23

On-Brand Devices [Leforte System Bone Screw]

• 08809265154747: 27L-MX-016
• 08809265154730: 27L-MX-014
• 08809265154723: 27L-MX-012
• 08809265154716: 27L-MX-010
• 08809265154709: 27L-MX-008
• 08809265154693: 27L-MX-006
• 08809265154686: 24L-MX-018
• 08809265154679: 24L-MX-016
• 08809265154662: 24L-MX-014
• 08809265154655: 24L-MX-012
• 08809265154648: 24L-MX-010
• 08809265154631: 24L-MX-008
• 08809265154624: 24L-MX-006
• 08809265154617: 24L-MX-005
• 08809265154600: 24L-MX-004
• 08809265154198: 23-MN-005
• 08809265154181: 23-MN-004
• 08809265154136: 27-MX-012
• 08809265154112: 27-MX-008
• 08809265154105: 27-MX-006
• 08809265154099: 24-MX-020
• 08809265154082: 24-MX-018
• 08809265154075: 24-MX-016
• 08809265154068: 24-MX-014
• 08809265154051: 24-MX-012
• 08809265154044: 24-MX-010
• 08809265154037: 24-MX-008
• 08809265154020: 24-MX-006
• 08809265154013: 24-MX-004
• 08809265153856: 23L-MN-016
• 08809265153849: 23L-MN-014
• 08809265153832: 23L-MN-012
• 08809265153825: 23L-MN-010
• 08809265153818: 23L-MN-008
• 08809265153801: 23L-MN-006
• 08809265153795: 20L-MN-018
• 08809265153788: 20L-MN-016
• 08809265153771: 20L-MN-014
• 08809265153764: 20L-MN-012
• 08809265153757: 20L-MN-010
• 08809265153740: 20L-MN-008
• 08809265153733: 20L-MN-006
• 08809265153726: 20L-MN-005
• 08809265153719: 20L-MN-004
• 08809265152125: 23-MN-008
• 08809265152118: 23-MN-006
• 08809265152101: 20-MN-020
• 08809265152095: 20-MN-018
• 08809265152088: 20-MN-016
• 08809265152071: 20-MN-014