DuraBurr

GUDID 06970399639843

Burr 5.5 Spherical Blade -12,SN_5

Hangzhou Rejoin Mastin Medical Device Co., Ltd.

Arthroscopic shaver system blade, single-use

• Primary Device ID: 06970399639843
• NIH Device Record Key: bfae9bae-8375-49b6-ad89-09df81c9d296
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraBurr
• Version Model Number: 800300200
• Company DUNS: 560430218
• Company Name: Hangzhou Rejoin Mastin Medical Device Co., Ltd.
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• 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
GS1	06970399639843 [Primary]

FDA Product Code

• HTT: Burr, Orthopedic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-26
• Device Publish Date: 2023-05-18

On-Brand Devices [DuraBurr]

• 06972884984759: Burr 5.5 Spherical Blade-12,ST_5
• 06972884984742: Burr 5.5 Turriform Blade -12,ST_5
• 06970399639843: Burr 5.5 Spherical Blade -12,SN_5
• 06970399639836: Burr 5.5 Turriform Blade-12,SN_5