INLET P.Humerus System Bone Plate

GUDID 08800089411528

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08800089411528
• NIH Device Record Key: 29fce3e0-515d-4a61-9fb2-dadab84fc3fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INLET P.Humerus System Bone Plate
• Version Model Number: IN35-PLHU-005-R
• 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	08800089411528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172008

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

[08800089411528]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-23
• Device Publish Date: 2021-11-15

On-Brand Devices [INLET P.Humerus System Bone Plate]

• 08800089411573: IN35-PLHU-003-L
• 08800089411566: IN35-PLHU-003-R
• 08800089411559: IN35-PLHU-004-L
• 08800089411542: IN35-PLHU-004-R
• 08800089411535: IN35-PLHU-005-L
• 08800089411528: IN35-PLHU-005-R