22mm x 10mm PLIF Trial Kit 8, 9, 10, 11 mm Heights

GUDID B064XM12289011

XENCO MEDICAL LLC

Bone file/rasp, manual

• Primary Device ID: B064XM12289011
• NIH Device Record Key: 641c548e-c4dd-4b9b-92ec-74d2bad0d27f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 22mm x 10mm PLIF Trial Kit 8, 9, 10, 11 mm Heights
• Version Model Number: XM-122-8901
• Company DUNS: 079282130
• Company Name: XENCO MEDICAL LLC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B064XM12289011 [Primary]

Sterilization

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

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

[B064XM12289011]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-12-07
• Device Publish Date: 2015-10-28

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