AADCO

Basic Information

• Brand Name: AADCO
• Primary DI: 00840348526196
• Version / Model: LP-210
• Catalog Number: LP-210
• Company Name: AADCO MEDICAL, INC.
• Labeler DUNS: 153603204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-12-15
• Public Version: 1
• Public Version Date: 2022-12-23
• Public Version Status: New
• Public Device Record Key: 10c06c06-a2d6-43aa-8fb0-7494990f529a

Device Description

X-1 RADIATION RESISTANT GLOVES SIZE 8

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EAJ	Apron, Leaded	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38366	Partial-hand radiation shield	A flat pad with a strap or partial glove assembly used to shield only a portion of the hand or fingers of the wearer from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. Some types can be designed to shield just the palm, others may shield only the dorsal surface of the hand and fingers. It typically consists of a fluid resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material and is typically intended to be worn over patient examination or surgical gloves.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00840348528367	GS1
Primary	00840348526196	GS1