Leforte Neuro System Bone Plate

GUDID 08809265151814

Jeil Medical Corporation

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 08809265151814
• NIH Device Record Key: d40e7cc4-8284-4675-b9eb-20f0bf85fd5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leforte Neuro System Bone Plate
• Version Model Number: N16-BR-011F
• 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	08809265151814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091679

FDA Product Code

• JEY: Plate, Bone

Sterilization

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

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

[08809265151814]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-09-24

On-Brand Devices [Leforte Neuro System Bone Plate]

• 08809265156208: N16-YP-005S
• 08809265155881: N12-SQ-104
• 08809265155874: N12-BR-021S
• 08809265155867: N12-BR-020S
• 08809265155850: N12-BR-011S
• 08809265155751: NS-3MA-200-06
• 08809265155744: NS-3MA-150-06
• 08809265155737: NS-3MD-100-06
• 08809265155720: NS-3MD-100-04
• 08809265155713: NS-3MA-100-06
• 08809265155706: NS-3MA-100-04
• 08809265155690: N16-CV-106
• 08809265155683: N16-CV-006
• 08809265155676: N16-SQ-004
• 08809265155669: N16-DY-106
• 08809265155652: N16-DY-006
• 08809265155645: N16-ST-006
• 08809265155638: N16-ST-104
• 08809265155621: N16-ST-004
• 08809265155614: N16-ST-102
• 08809265155607: N16-ST-002
• 08809265155591: N12-BR-010S
• 08809265155584: N12-GP-030S
• 08809265155577: N12-GP-020S
• 08809265155560: N12-GP-010S
• 08809265155553: N12-ME-001-05
• 08809265155515: N12-ME-002-05
• 08809265155492: N12-ST-102
• 08809265155485: N12-DY-106
• 08809265155478: N12-DY-006
• 08809265155461: N12-ST-002
• 08809265155454: N12-CV-002
• 08809265155447: N12-CV-001
• 08809265155430: N12-QD-008
• 08809265155423: N12-SQ-004
• 08809265155416: N12-ST-006
• 08809265155409: N12-ST-005
• 08809265151937: N16-GP-030S
• 08809265151920: N16-GP-020S
• 08809265151913: N16-GP-010S
• 08809265151906: N16-BR-021S
• 08809265151890: N16-BR-020S
• 08809265151883: N16-BR-011S
• 08809265151876: N16-BR-010S
• 08809265151869: N16-GP-030F
• 08809265151852: N16-GP-020F
• 08809265151845: N16-GP-010F
• 08809265151838: N16-BR-021F
• 08809265151821: N16-BR-020F
• 08809265151814: N16-BR-011F