WOLF

GUDID B15081080012

DISPOSABLE, BIPOLAR CABLE

NURSE ASSIST, INC.

Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use

• Primary Device ID: B15081080012
• NIH Device Record Key: 7f09a1a4-8f85-40eb-91bd-5fb7aaad098f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WOLF
• Version Model Number: 8108.001
• Company DUNS: 869434464
• Company Name: NURSE ASSIST, INC.
• Device Count: 10
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B15081080010 [Unit of Use]
HIBCC	B15081080012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942194

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [WOLF]

• B15081080114: 8108.011
• B15081080112: 8108.011
• B15081080014: DISPOSABLE, BIPOLAR CABLE
• B15081080012: DISPOSABLE, BIPOLAR CABLE