INLET Foot 2.3 2.8 System Bone Plate

GUDID 08800089412877

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08800089412877
• NIH Device Record Key: befb5956-ab70-435a-9fff-30cdaf308599
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INLET Foot 2.3 2.8 System Bone Plate
• Version Model Number: INF28-LL-004-16
• 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	08800089412877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170780

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

[08800089412877]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-24
• Device Publish Date: 2021-11-16

On-Brand Devices [INLET Foot 2.3 2.8 System Bone Plate]

• 08800089413287: INF23-GR-006-13
• 08800089413270: INF23-GR-008-13
• 08800089413263: INF23-GR-009-13
• 08800089413256: INF23-LL-004-13
• 08800089413249: INF23-LL-005-13
• 08800089413232: INF23-LL-104-13
• 08800089413225: INF23-LL-105-13
• 08800089413218: INF23-LL-204-13
• 08800089413201: INF23-LL-205-13
• 08800089413195: INF23-LL-304-13
• 08800089413188: INF23-LL-305-13
• 08800089413171: INF23-LR-004-13
• 08800089413164: INF23-LR-005-13
• 08800089413157: INF23-LR-104-13
• 08800089413140: INF23-LR-105-13
• 08800089413133: INF23-LR-204-13
• 08800089413126: INF23-LR-205-13
• 08800089413119: INF23-LR-304-13
• 08800089413102: INF23-LR-305-13
• 08800089413096: INF23-QL-006-13
• 08800089413089: INF23-QL-008-13
• 08800089413072: INF23-QR-006-13
• 08800089413065: INF23-QR-008-13
• 08800089413058: INF23-ST-002-13
• 08800089413041: INF23-ST-004-13
• 08800089413034: INF23-ST-005-13
• 08800089413027: INF23-ST-006-13
• 08800089413010: INF23-ST-102-13
• 08800089413003: INF23-TL-004-13
• 08800089412990: INF23-TL-005-13
• 08800089412983: INF23-TR-004-13
• 08800089412976: INF23-TR-005-13
• 08800089412969: INF23-XL-004-13
• 08800089412952: INF23-XL-104-13
• 08800089412945: INF23-XL-204-13
• 08800089412938: INF23-XR-004-13
• 08800089412921: INF23-XR-104-13
• 08800089412914: INF23-XR-204-13
• 08800089412907: INF28-GR-006-16
• 08800089412891: INF28-GR-008-16
• 08800089412884: INF28-GR-009-16
• 08800089412877: INF28-LL-004-16
• 08800089412860: INF28-LL-005-16
• 08800089412853: INF28-LL-104-16
• 08800089412846: INF28-LL-105-16
• 08800089412839: INF28-LL-204-16
• 08800089412822: INF28-LL-205-16
• 08800089412815: INF28-LL-304-16
• 08800089412808: INF28-LL-305-16
• 08800089412792: INF28-LR-004-16