Duns Number:187502109
Device Description: ACL DISPOSABLE PACK - SOFT TISSUE FIXATION (6 PER PKG)
Catalog Number
234-020-290
Brand Name
NA
Version/Model Number
234-020-290
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
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
KDD
Product Code Name
KIT, SURGICAL INSTRUMENT, DISPOSABLE
Public Device Record Key
aaf6597c-e125-4b6c-8f83-3accc9f45f33
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 09, 2015
Package DI Number
37613154643272
Quantity per Package
6
Contains DI Package
07613154643271
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |