Duns Number:486711679
Device Description: LCP® SUP CLAVICLE TEMPL 8H /R ANATOMIC TEMPLATE
Catalog Number
03133362
Brand Name
NA
Version/Model Number
03.133.362
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HWT
Product Code Name
TEMPLATE
Public Device Record Key
0667310e-2ecf-4cde-8851-55b493dc74a1
Public Version Date
May 02, 2022
Public Version Number
2
DI Record Publish Date
January 15, 2021
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 | 8630 |
2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
U | Unclassified | 2 |