Pedicle Screw Instruments Kit

GUDID B064XM11510001

XENCO MEDICAL LLC

Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use

• Primary Device ID: B064XM11510001
• NIH Device Record Key: 5571e6de-27a7-474a-bbbf-d86120164db0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pedicle Screw Instruments Kit
• Version Model Number: XM-115-1000
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B064XM11510001 [Primary]

Sterilization

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

[B064XM11510001]

Radiation Sterilization

[B064XM11510001]

Radiation Sterilization

[B064XM11510001]

Radiation Sterilization

[B064XM11510001]

Radiation Sterilization

[B064XM11510001]

Radiation Sterilization

[B064XM11510001]

Radiation Sterilization

[B064XM11510001]

Radiation Sterilization

[B064XM11510001]

Radiation Sterilization

[B064XM11510001]

Radiation Sterilization

[B064XM11510001]

Radiation Sterilization

[B064XM11510001]

Radiation Sterilization

[B064XM11510001]

Radiation Sterilization

[B064XM11510001]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-19
• Device Publish Date: 2022-08-11

Devices Manufactured by XENCO MEDICAL LLC

• B064HB11200101 - Tube Guard: 2023-08-15
• B064MPE010101 - Saratoga Cervical Brace: 2023-08-15
• B064MPE010401 - Tahiti Lumbar Brace: 2023-08-15
• B064XM11510001 - Pedicle Screw Instruments Kit: 2022-08-19
• B064XM11510001 - Pedicle Screw Instruments Kit: 2022-08-19
• B064XM12323451 - 23mm x 10mm PLIF Trial Kit 12, 13, 14, 15 mm Heights: 2020-04-06 23mm x 10mm PLIF Trials: 12, 13, 14, 15 mm Heights
• B064XM12723451 - 27mm x 12mm TLIF Trial Kit 12, 13, 14, 15 mm Heights: 2020-04-06 27mm x 12mm TLIF Trials: 12, 13, 14, 15 mm Heights
• B064XM12789011 - 27mm x 12mm TLIF Trial Kit 8, 9, 10, 11 mm Heights: 2020-04-06
• B064XM12823451 - 28mm x 11mm Oblique Trials 12, 13, 14, 15 mm Heights: 2020-04-06 28mm x 11mm Oblique Trial Kit 12, 13, 14, 15 mm Heights