Dissection Needle B68000

GUDID B089B680000

MICRO ONYX DISSECTION NEEDLE "COLORADO TYPE"; 1 3/4"(4.3CM), STRAIGHT

BLACK & BLACK SURGICAL, INC.

Open-surgery electrosurgical electrode, monopolar, reusable

• Primary Device ID: B089B680000
• NIH Device Record Key: 0541879c-df4e-49ec-bf16-37d5d0d6f921
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dissection Needle
• Version Model Number: B68000
• Catalog Number: B68000
• Company DUNS: 004382282
• Company Name: BLACK & BLACK SURGICAL, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B089B680000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072124

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[B089B680000]

Moist Heat or Steam Sterilization

[B089B680000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-29

On-Brand Devices [ Dissection Needle]

• B089B680350: MICRO ONYX DISSECTION NEEDLE; 5 1/4"(13.3CM), 45 DEGREE TIP
• B089B680300: MICRO ONYX DISSECTION NEEDLE "COLORADO TYPE"; 5 1/4"(13.3CM), STRAIGHT
• B089B680250: MICRO ONYX DISSECTION NEEDLE "COLORADO TYPE"; 3 3/4"(9.3CM), 45 DEGREE TIP
• B089B680200: MICRO ONYX DISSECTION NEEDLE "COLORADO TYPE"; 3 3/4"(9.3CM), STRAIGHT
• B089B680160: MICRO ONYX DISSECTION NEEDLE; 2 3/4"(7CM) 45 DEGREE TIP
• B089B680150: MICRO ONYX DISSECTION NEEDLE "COLORADO TYPE"; 2 1/2"(6.3CM), 45 DEGREE TIP
• B089B680100: MICRO ONYX DISSECTION NEEDLE "COLORADO TYPE"; 1 3/4"(4.3CM), 45 DEGREE TIP
• B089B680050: MICRO ONYX DISSECTION NEEDLE "COLORADO TYPE"; 2 1/2"(6.3CM), STRAIGHT
• B089B680000: MICRO ONYX DISSECTION NEEDLE "COLORADO TYPE"; 1 3/4"(4.3CM), STRAIGHT