ENDOPLASTIC SCOPE B65910

GUDID B089B659100

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

BLACK & BLACK SURGICAL, INC.

Rigid 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