Rayshield

Primary DI
00840348500899
Brand
Rayshield
Company
AADCO MEDICAL, INC.
Model
LG-FRAK
Catalog number
LG-FRAK
Device description
RAYSHIELD STYLE-FIT DESIGNER EYEWEAR FRANKLIN- MATTE BLACK
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IWSShield, Eye, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
IWSShield, Eye, RadiologicalRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840348500899PrimaryGS10

GMDN Terms

TermDefinition
Radiation shielding goggles/spectaclesA personal protective device in the form of eyewear/glasses with clear lenses intended to be used to shield the eyes of healthcare staff from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. It is designed as uncorrected (non-prescription) or corrected (prescription) goggles or spectacles with lenses and side shields made of radiation-protecting materials (e.g., glass, plastic). The lenses and side shields offer additional physical barrier protection from liquid radioactive materials.

Sterilization Methods

Method

Regulatory Flags

DUNS number
153603204
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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