Duns Number:109903521
Device Description: EUR/UK LATERAL RAIL CLAMPS 2 0.394 INCH X 0.984 INCH 1 EUR/UK LATERAL RAIL CLAMPS 2 0.394 INCH X 0.984 INCH 1 CM X 2.6 CM, 0.250 INCH X 1.250 INCH 1 CM X 2.6 CM
Catalog Number
72200675
Brand Name
NA
Version/Model Number
72200675
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
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
20d68e28-0272-40cd-9ffe-a3d8df6522ae
Public Version Date
October 07, 2020
Public Version Number
3
DI Record Publish Date
August 29, 2015
Package DI Number
23596010595366
Quantity per Package
2
Contains DI Package
03596010595362
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |