Duns Number:044516217
Device Description: 5 Piece ClikRay (TM) Kodak Size 1 Holder
Catalog Number
001-107
Brand Name
5 Piece ClikRay (TM) Kodak Size 1 Holder
Version/Model Number
001-107
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EGZ
Product Code Name
Holder, Film, X-Ray
Public Device Record Key
8970c2d5-e0fd-4b43-8548-a8b35148e348
Public Version Date
January 08, 2021
Public Version Number
1
DI Record Publish Date
December 31, 2020
Package DI Number
10856200001104
Quantity per Package
16
Contains DI Package
00856200001107
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 84 |