ENDOPLASTIC SCOPE B65910

GUDID B089B659100

ENDOPLASTIC SCOPE; 7''(17.5CM), 30 DEGREE, 10MM DIAMETER

BLACK & BLACK SURGICAL, INC.

Rigid arthroscope, reusable Rigid arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable Rigid optical arthroscope, reusable

• Primary Device ID: B089B659100
• NIH Device Record Key: 7779bc7d-1f35-4a7f-aacd-a7309e4fc57c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOPLASTIC SCOPE
• Version Model Number: B65910
• Catalog Number: B65910
• 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
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com
• Phone: 877-252-2517
• Email: info@blackandblacksurgical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B089B659100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943426

FDA Product Code

• HRX: Arthroscope

Sterilization

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

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

Moist Heat or Steam Sterilization

[B089B659100]

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: 2016-09-20

On-Brand Devices [ENDOPLASTIC SCOPE]

• B089B659660: ENDOPLASTIC SCOPE; 12''(33CM, )30 DEGREE, 10MM DIAMETER,
• B089B659250: ENDOPLASTIC SCOPE; 12''(33CM), 0 DEGREE, 10MM DIAMETER
• B089B659220: ENDOPLASTIC SCOPE; 7"(18CM), 0 DEGREE, 4MM DIAMETER
• B089B659210: ENDOPLASTIC SCOPE; 7''(17.5CM), 30 DEGREE, 4MM DIAMETER,
• B089B659200: ENDOPLASTIC SCOPE; 7"(17.5CM), 30 DEGREE, 5MM DIAMETER
• B089B659100: ENDOPLASTIC SCOPE; 7''(17.5CM), 30 DEGREE, 10MM DIAMETER