Duns Number:621134084
Device Description: OR Quick Release radiation protection apron is designed for quick release in the OR withou OR Quick Release radiation protection apron is designed for quick release in the OR without compromising the sterile field. Adjustable elastic inserts in the rear flaps offer greater comfort, adjustment and support. Just release the Velcro straps at the hips and the aprons falls off. Shoulder pads provide additional support.
Catalog Number
-
Brand Name
OR Quick Release Radiation Protection Apron-Pb Free-XX Large
Version/Model Number
ORQ-PbF-XXL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EAJ
Product Code Name
Apron, Leaded
Public Device Record Key
a427d1f3-1f60-4210-94a3-2d6256c1ce3a
Public Version Date
October 14, 2022
Public Version Number
1
DI Record Publish Date
October 06, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 107 |