Saratoga Cervical Brace

GUDID B064MPE010101

XENCO MEDICAL LLC

Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable Cervical spine collar, reusable

• Primary Device ID: B064MPE010101
• NIH Device Record Key: d3016a81-54bc-415a-9a8c-d2956ac741e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saratoga Cervical Brace
• Version Model Number: MPE01010
• Company DUNS: 079282130
• Company Name: XENCO MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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
HIBCC	B064MPE010101 [Primary]

FDA Product Code

• IQK: Orthosis, Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-15
• Device Publish Date: 2023-08-07

Devices Manufactured by XENCO MEDICAL LLC

• B064HB11200101 - Tube Guard: 2023-08-15
• B064MPE010101 - Saratoga Cervical Brace: 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
• 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