Oakworks, Inc.

GUDID 00817463022544

Spine Positioning System II Large Torso - TT/EM

OAKWORKS, INC.

Head/neck procedure positioner

• Primary Device ID: 00817463022544
• NIH Device Record Key: 4530ee91-6178-467a-9782-8276d816e606
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oakworks, Inc.
• Version Model Number: Spine Positioning System II
• Company DUNS: 130256837
• Company Name: OAKWORKS, INC.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817463022544 [Primary]

FDA Product Code

• KXH: Cradle, Patient, Radiologic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-12

On-Brand Devices [Oakworks, Inc.]

• 00817463022544: Spine Positioning System II Large Torso - TT/EM
• 00817463022537: Spine Positioning System II Large Torso - TT
• 00817463022452: Prone Pillow
• 00817463022445: Interventional Supine Pillow System
• 00817463022438: Patient Safety Strap
• 00817463022421: Arm Hammock