Palmero Healthcare, LLC

Basic Information

• Brand Name: Palmero Healthcare, LLC
• Primary DI: 00840415101646
• Version / Model: 1970
• Catalog Number: 1970
• Company Name: Palmero Healthcare LLC
• Labeler DUNS: 080530675
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-05
• Public Version: 2
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 0164547d-da54-4a5e-8de1-9fccefb5fb51

Device Description

DIGITAL X-RAY SENSOR PROTECTOR SMALL

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
NRU	Chair, Dental, Without Operative Unit	Dental	872.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment drape, single-use	A 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 neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840415101646	GS1

Customer Contacts

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