ITN Implant EXITN924555

GUDID B487EXITN9245550

ITN Implant is a stainless steel bone screw

EXSOMED CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband Stress-therapy vibroacoustic headband

• Primary Device ID: B487EXITN9245550
• NIH Device Record Key: d2543b8e-b2fd-430b-9f26-09903464665d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ITN Implant
• Version Model Number: EXITN924555
• Catalog Number: EXITN924555
• Company DUNS: 116722111
• Company Name: EXSOMED 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B487EXITN9245550 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-16
• Device Publish Date: 2018-04-06

On-Brand Devices [ITN Implant]

• B487EXITN9245750: ITN Implant is a stainless steel bone screw
• B487EXITN9245650: ITN Implant is a stainless steel bone screw
• B487EXITN9245550: ITN Implant is a stainless steel bone screw
• B487EXITN9245500: ITN Implant is a stainless steel bone screw
• B487EXITN9245450: ITN Implant is a stainless steel bone screw
• B487EXITN9245400: ITN Implant is a stainless steel bone screw
• B487EXITN9245350: ITN Implant is a stainless steel bone screw