INLET System Bone Screw

GUDID 08800089411795

Jeil Medical Corporation

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 08800089411795
• NIH Device Record Key: 5cb826b3-3c8e-4b78-a06e-cc156a433ecc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INLET System Bone Screw
• Version Model Number: IN15-HC-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	08800089411795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131566

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

Moist Heat or Steam Sterilization

[08800089411795]

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 System Bone Screw]

• 08800089412129: IN15L-HF-006
• 08800089412112: IN15L-HF-007
• 08800089412105: IN15L-HF-009
• 08800089412099: IN15L-HF-011
• 08800089412082: IN15L-HF-013
• 08800089412075: IN15L-HF-014
• 08800089412068: IN15L-HF-016
• 08800089412051: IN15L-HF-018
• 08800089412044: IN15L-HF-020
• 08800089412037: IN20-HF-006
• 08800089412020: IN20-HF-007
• 08800089412013: IN20-HF-008
• 08800089412006: IN20-HF-009
• 08800089411993: IN20-HF-010
• 08800089411986: IN20-HF-011
• 08800089411979: IN20-HF-012
• 08800089411962: IN20-HF-013
• 08800089411955: IN20-HF-014
• 08800089411948: IN20-HF-016
• 08800089411931: IN20-HF-018
• 08800089411924: IN20-HF-020
• 08800089411917: IN20L-HF-006
• 08800089411900: IN20L-HF-007
• 08800089411894: IN20L-HF-008
• 08800089411887: IN20L-HF-009
• 08800089411870: IN20L-HF-010
• 08800089411863: IN20L-HF-011
• 08800089411856: IN20L-HF-012
• 08800089411849: IN20L-HF-013
• 08800089411832: IN20L-HF-014
• 08800089411825: IN20L-HF-016
• 08800089411818: IN20L-HF-018
• 08800089411801: IN20L-HF-020
• 08800089411795: IN15-HC-006
• 08800089411788: IN15-HC-007
• 08800089411771: IN15-HC-008
• 08800089411764: IN15-HC-009
• 08800089411757: IN15-HC-010
• 08800089411740: IN15-HC-011
• 08800089411733: IN15-HC-012
• 08800089411726: IN15-HC-013
• 08800089411719: IN15-HC-014
• 08800089411702: IN15-HC-016
• 08800089411696: IN15-HC-018
• 08800089411689: IN15-HC-020
• 08800089411672: IN18-HC-006
• 08800089411665: IN18-HC-010
• 08800089411658: IN23-FC-006
• 08800089411641: IN23-FC-010
• 08800089411580: IN40L-SA-052-TA