Duns Number:138041277
Device Description: Ratchet T Handle Jacobs Chuck
Catalog Number
HNDL-RATCH T
Brand Name
Generic Instruments
Version/Model Number
HNDL-RATCH T
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)
-
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
31bd2122-8d0f-4db3-91d0-9f9b453c604e
Public Version Date
August 09, 2018
Public Version Number
4
DI Record Publish Date
September 14, 2017
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 | 555 |
2 | A medical device with a moderate to high risk that requires special controls. | 1934 |