Duns Number:043505370
Device Description: Locking Peg, 2.7mm x 26mm Long
Catalog Number
-
Brand Name
Locking Peg, 2.7mm x 26mm Long
Version/Model Number
PG2726
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
K191118
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
db8d299d-7e74-4d0d-a8b4-71f621eb8fec
Public Version Date
November 06, 2020
Public Version Number
1
DI Record Publish Date
October 29, 2020
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 181 |