INLET Elbow System Bone Plate

GUDID 08800089414192

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08800089414192
• NIH Device Record Key: 18931b7b-3eb8-473a-b83a-cd4aca6e9ef2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INLET Elbow System Bone Plate
• Version Model Number: IN20-PLRA-310
• 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	08800089414192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201656

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

[08800089414192]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-25
• Device Publish Date: 2021-11-17

On-Brand Devices [INLET Elbow System Bone Plate]

• 08800089413805: IN35-PLUL-008-L
• 08800089413799: IN35-PLUL-008-R
• 08800089413782: IN35-PLUL-104-L
• 08800089413775: IN35-PLUL-104-R
• 08800089413768: IN35-PLUL-105-L
• 08800089413751: IN35-PLUL-105-R
• 08800089414246: IN20-PLRA-107
• 08800089414239: IN20-PLRA-109
• 08800089414222: IN20-PLRA-208
• 08800089414215: IN20-PLRA-210
• 08800089414208: IN20-PLRA-308
• 08800089414192: IN20-PLRA-310
• 08800089414185: IN25-PLUL-005
• 08800089414178: IN25-PLUL-006
• 08800089414161: IN25-PLUL-007
• 08800089414154: IN25-PLUL-009
• 08800089414147: IN25-PLUL-105
• 08800089414130: IN25-PLUL-106
• 08800089414123: IN25-PLUL-107
• 08800089414116: IN25-PLUL-109
• 08800089414109: IN35-DLHU-102-L
• 08800089414093: IN35-DLHU-102-R
• 08800089414086: IN35-DLHU-103-L
• 08800089414079: IN35-DLHU-103-R
• 08800089414062: IN35-DLHU-105-L
• 08800089414055: IN35-DLHU-105-R
• 08800089414048: IN35-DLHU-107-L
• 08800089414031: IN35-DLHU-107-R
• 08800089414024: IN35-DMHU-201-L
• 08800089414017: IN35-DMHU-201-R
• 08800089414000: IN35-DMHU-202-L
• 08800089413997: IN35-DMHU-202-R
• 08800089413980: IN35-DMHU-204-L
• 08800089413973: IN35-DMHU-204-R
• 08800089413966: IN35-DMHU-206-L
• 08800089413959: IN35-DMHU-206-R
• 08800089413942: IN35-DPHU-103-L
• 08800089413935: IN35-DPHU-103-R
• 08800089413928: IN35-DPHU-104-L
• 08800089413911: IN35-DPHU-104-R
• 08800089413904: IN35-DPHU-106-L
• 08800089413898: IN35-DPHU-106-R
• 08800089413881: IN35-DPHU-108-L
• 08800089413874: IN35-DPHU-108-R
• 08800089413867: IN35-PLUL-004-L
• 08800089413850: IN35-PLUL-004-R
• 08800089413843: IN35-PLUL-005-L
• 08800089413836: IN35-PLUL-005-R
• 08800089413829: IN35-PLUL-007-L
• 08800089413812: IN35-PLUL-007-R