INLET New Hand System Bone Plate

GUDID 08800089412181

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 08800089412181
• NIH Device Record Key: daf3bea9-b6fb-409e-a0f2-3ecc6d1cd804
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INLET New Hand System Bone Plate
• Version Model Number: INH1L-YP-006
• 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	08800089412181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161746

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

Moist Heat or Steam Sterilization

[08800089412181]

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 New Hand System Bone Plate]

• 08800089412396: INH2L-LR-010-13
• 08800089412389: INH2L-LL-010-13
• 08800089412372: INH2L-LR-006-13
• 08800089412365: INH2L-LL-006-13
• 08800089412358: INH2L-TP-010-13
• 08800089412341: INH2L-TP-006-13
• 08800089412334: INH2L-ST-208-13
• 08800089412327: INH2L-ST-106-13
• 08800089412310: INH2L-ST-105-13
• 08800089412303: INH2L-ST-104-13
• 08800089412297: INH2L-LR-006
• 08800089412280: INH2L-LL-006
• 08800089412273: INH2L-YP-007
• 08800089412266: INH2L-YP-006
• 08800089412259: INH2L-TP-007
• 08800089412242: INH2L-QD-006
• 08800089412235: INH2L-ST-016
• 08800089412228: INH2L-ST-006
• 08800089412211: INH2L-ST-004
• 08800089412204: INH1L-LR-005
• 08800089412198: INH1L-LL-005
• 08800089412181: INH1L-YP-006
• 08800089412174: INH1L-TP-007
• 08800089412167: INH1L-QD-112
• 08800089412150: INH1L-ST-104
• 08800089412143: INH1L-ST-016
• 08800089412136: INH1L-ST-006