Duns Number:117858154
Catalog Number
-
Brand Name
5.0mm Pin Guide Multi-Pin Clamp
Version/Model Number
0366
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 22, 2018
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
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
60dd4d00-458a-4768-906d-bffd12a57a52
Public Version Date
June 24, 2020
Public Version Number
5
DI Record Publish Date
January 22, 2018
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 | 542 |
2 | A medical device with a moderate to high risk that requires special controls. | 2485 |