Spine Pro

GUDID 00848657067300

Spine Pro Bayonet Kerrison, 5mm, 230mm, 40 degree

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Bone punch, reusable

• Primary Device ID: 00848657067300
• NIH Device Record Key: b8859223-e296-4c36-a78e-9b28e37d5444
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spine Pro
• Version Model Number: 2805
• Company DUNS: 839138955
• Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848657067300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023868

FDA Product Code

• HAE: RONGEUR, MANUAL

Sterilization

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

[00848657067300]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-26

On-Brand Devices [Spine Pro]

• 00848657074384: Spine Pro Bayonet Pituitary Biopsy 230mm, 40 Degree
• 00848657067300: Spine Pro Bayonet Kerrison, 5mm, 230mm, 40 degree
• 00848657067294: Spine Pro Bayonet Kerrison, 4mm, 230mm, 40 degree
• 00848657067287: Spine Pro Bayonet Kerrison, 3mm, 230mm, 40 degree
• 00848657067270: Spine Pro Bayonet Kerrison, 2mm, 230mm, 40 degree
• 00848657067263: Spine Pro Bayonet Kerrison, 1mm, 230mm, 40 degree