Sklar®

Basic Information

• Brand Name: Sklar®
• Primary DI: 10649111279638
• Version / Model: 10-1114
• Company Name: SKLAR CORPORATION
• Labeler DUNS: 006966006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5e3de3ce-afcd-4c06-a3b3-64328b8c4ff2

Device Description

STEAM INDICATOR PEN

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOJ	Indicator, physical/chemical sterilization process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37284	Enzymatic sterilization indicator	A strip or tape coated with an enzyme that changes colour when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10649111279638	GS1

Premarket Submissions

Submission Number	Supplement Number
K890759	000