StripRight

Basic Information

• Brand Name: StripRight
• Primary DI: B145113800
• Version / Model: 11380
• Company Name: OPTICAL INTEGRITY INC
• Labeler DUNS: 024050887
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-03
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7b3a1745-9312-4fb0-830b-02f9ebda384c

Device Description

200 µm StripRight Fiber Strip and Scribe Tool

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRT	STRIPPER, SURGICAL	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48018	Laser fibre stripper	A non-sterile, hand-held device used by authorized medical personnel to strip the outer protective layer (i.e., casing, jacket or buffer) from the end of a laser fibreoptic device without damaging the fibreoptics so that the bared end can be prepared for the next procedure (e.g, cleaving and repair). It is available in various designs and configurations, e.g., in the form of an electrical cable stripper (a pliers-like device) with two blades that hinge at a proximal end which are clamped over the fibreoptic device to be stripped and a mechanically adjustable depth limiter. It is configured to accept and strip one size or type of fibreoptic.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B145114771	HIBCC	box	5	In Commercial Distribution
Primary	B145113800	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: store at room temperature
• Type: Storage Environment Temperature
• Temperature Range: 10 – 37 Degrees Celsius