Sentient Manufacturing

Basic Information

• Brand Name: Sentient Manufacturing
• Primary DI: 00860007603747
• Version / Model: 3041310
• Company Name: Sentient Manufacturing, LLC
• Labeler DUNS: 106674754
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-16
• Public Version: 2
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: bf4267cf-8653-48ea-8ee6-5c46a81b266a

Device Description

Sentient Manufacturing Laser Fiber Cleaver

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48016	Laser fibre cleaving tool	A non-sterile, manually-operated instrument used to cleave (remove with a clean cut) the tip of a reusable laser fibre, e.g., a laser-beam delivery device. It is designed to be placed on a flat solid surface away from the clinical setting, and the end of the fibre to be cut is manually scored when passed across the cutting cleaver (e.g., a diamond coated wheel). It is used to cleave the fibre core to remove cracked, chipped, and damaged tips from a reusable medical device so that this can be successfully reused for further procedures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007603747	GS1