FDA.report

Techno-Aide

Primary DI
G242WL5L90
Brand
Techno-Aide
Company
Techno-Aide, Inc.
Model
WL-5L
Catalog number
WL-5L
Device description
EZ Reverse Full Wrap Vests LARGE - 0.50mm Lead Equivalence-LIGHTWEIGHTPROTECTIVE MEDIA
Published
2023-06-08
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

Contact Domains

Product Codes

CodeName
IWOApron, protective

Product Code Classifications

CodeDeviceSpecialtyClass
IWOApron, ProtectiveRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G242WL5L90PackageHIBCC1In Commercial Distribution
G242WL5L9PrimaryHIBCC0

GMDN Terms

TermDefinition
Radiation shielding apronA full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(615)350-7030Customerservice@Techno-Aide.com

Regulatory Flags

DUNS number
843929279
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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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