SINGLE USE SLEEVES - 3D BITE BLOCK

Basic Information

• Brand Name: SINGLE USE SLEEVES - 3D BITE BLOCK
• Primary DI: 60192155302886
• Version / Model: SINGLE USE SLEEVES - 3D BITE BLOCK
• Catalog Number: 5302880
• Company Name: CARESTREAM DENTAL LLC
• Labeler DUNS: 019796106
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-15
• Public Version: 5
• Public Version Date: 2019-10-17
• Public Version Status: Update
• Public Device Record Key: 4a8ab577-159f-4b44-abce-3b22efdd7b59

Device Description

SINGLE USE SLEEVES - 3D BITE BLOCK

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• 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
KQM	CAMERA, SURGICAL AND ACCESSORIES	General, Plastic Surgery	878.4160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63712	Medical equipment drape, single-use, non-sterile	A non-sterile flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is not a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	60192155302886	GS1