Cranial LOOP

GUDID 48437006085043

Cranial Fixation System

NEOS SURGERY SL

Cranial bur hole cover Cranial bur hole cover

• Primary Device ID: 48437006085043
• NIH Device Record Key: 7ded4938-0c7f-4805-a250-c9b981e4334d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cranial LOOP
• Version Model Number: FC050000
• Company DUNS: 465890437
• Company Name: NEOS SURGERY SL
• 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: 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

Customer Support Contacts

• Phone: 999 999 9999
• Email: info@neosurgery.com
• Phone: 999 999 9999
• Email: info@neosurgery.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18437006085042 [Primary]
GS1	28437006085049 [Package]; Contains: 18437006085042; Package: [64 Units]; In Commercial Distribution
GS1	38437006085046 [Package]; Contains: 18437006085042; Package: [6 Units]; In Commercial Distribution
GS1	48437006085043 [Package]; Contains: 38437006085046; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132044

FDA Product Code

• GXR: Cover, Burr Hole

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-08

Devices Manufactured by NEOS SURGERY SL

• 48437006085043 - Cranial LOOP: 2018-07-06Cranial Fixation System
• 48437006085043 - Cranial LOOP: 2018-07-06 Cranial Fixation System
• 18437006085059 - Cranial LOOP L: 2018-07-06 Cranial Fixation System
• 48437006085067 - Cranial LOOP XL: 2018-07-06 Cranial Fixation System