Duns Number:353939929
Device Description: Clip Attachment with Spacer Oval
Catalog Number
DCA 156-0
Brand Name
NA
Version/Model Number
DCA 156-0
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 2019
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EGG
Product Code Name
ATTACHMENT, PRECISION, ALL
Public Device Record Key
ecdbe58b-a6ce-43dd-9439-d30157c24426
Public Version Date
November 08, 2019
Public Version Number
6
DI Record Publish Date
September 17, 2016
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 | 782 |
2 | A medical device with a moderate to high risk that requires special controls. | 3680 |