Leforte Neuro System Bone Plate

GUDID 08806390888851

Jeil Medical Corporation

Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable Cranioplasty plate, alterable

• Primary Device ID: 08806390888851
• NIH Device Record Key: 66efd10e-b4b9-4b3b-bf79-583e8d73c73c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leforte Neuro System Bone Plate
• Version Model Number: N16-SQ-104
• 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	08806390888851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112812

FDA Product Code

• HBW: Fastener, Plate, Cranioplasty

Sterilization

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

[08806390888851]

Moist Heat or Steam Sterilization

[08806390888851]

Moist Heat or Steam Sterilization

[08806390888851]

Moist Heat or Steam Sterilization

[08806390888851]

Moist Heat or Steam Sterilization

[08806390888851]

Moist Heat or Steam Sterilization

[08806390888851]

Moist Heat or Steam Sterilization

[08806390888851]

Moist Heat or Steam Sterilization

[08806390888851]

Moist Heat or Steam Sterilization

[08806390888851]

Moist Heat or Steam Sterilization

[08806390888851]

Moist Heat or Steam Sterilization

[08806390888851]

Moist Heat or Steam Sterilization

[08806390888851]

Moist Heat or Steam Sterilization

[08806390888851]

Moist Heat or Steam Sterilization

[08806390888851]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-11
• Device Publish Date: 2022-05-03

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