Disposable Brain Biopsy Needle Kit MDBN-08-28X

GUDID 00841823106674

AD-TECH MEDICAL INSTRUMENT CORPORATION

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• Primary Device ID: 00841823106674
• NIH Device Record Key: 616b3d3f-df5c-4161-9029-0c06429fbb6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Brain Biopsy Needle Kit
• Version Model Number: MDBN-08-28X
• Catalog Number: MDBN-08-28X
• Company DUNS: 174813410
• Company Name: AD-TECH MEDICAL INSTRUMENT CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com
• Phone: +1(800)776-1555
• Email: sales@adtechmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
• Special Storage Condition, Specify: Between 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841823106674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112094

FDA Product Code

• FCG: Biopsy needle

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: 2016-09-23

On-Brand Devices [Disposable Brain Biopsy Needle Kit]

• 00841823106674: MDBN-08-28X
• 00841823100979: DBN-10-24X
• 00841823100962: DBN-10-19X
• 00841823100955: DBN-10-10X
• 00841823100948: DBN-08-24X
• 00841823100931: DBN-08-19X
• 00841823100924: DBN-08-15X
• 00841823100917: DBN-08-10X
• 00841823100900: DBN-05-24X
• 00841823100894: DBN-05-19X
• 00841823100887: DBN-05-15X
• 00841823100870: DBN-05-10X