InstaClear

Basic Information

• Brand Name: InstaClear
• Primary DI: 00821925040199
• Version / Model: LCS1570BTOL
• Company Name: Gyrus Acmi, Inc.
• Labeler DUNS: 007198742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-05
• Public Version: 7
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 282f92ec-8b1f-4f9d-95f2-5e7e6e3dcf5b

Device Description

SHEATH, LENS CLEANER OLYMPUS 70 DEGREES, for use with Olympus 4 x 150 mm scopes, BOTTOM LIGHT InstaClear

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EOB	NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)	Ear, Nose, Throat	874.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61204	Endoscope lens cleaner, gas/fluid, single-use	A sterile device intended to be used for the in situ removal of fog/blood/debris from the lens of an endoscope (e.g., laparoscope), by directing gas and/or liquid to the edge of the lens. It is typically a multichannel sleeve with connection tubing. Gases/fluids are intended to be directed from a source through the channels within the sleeve to the lens. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00821925040021	GS1		5	In Commercial Distribution
Primary	00821925040199	GS1

Premarket Submissions

Submission Number	Supplement Number
K152531	000