Duns Number:024163331
Device Description: Guides are stainless steel parts of various designs that allow various drill diameters. So Guides are stainless steel parts of various designs that allow various drill diameters. Some guides are laser weld assemblies with a handle, and others are threaded to screw into plates.
Catalog Number
TO-FIX-CEGS
Brand Name
Cross Element Guide Sleeve
Version/Model Number
NA
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
GCZ
Product Code Name
Retainer, Surgical
Public Device Record Key
57568f34-a144-471e-b89d-e7292e9b57be
Public Version Date
September 07, 2020
Public Version Number
1
DI Record Publish Date
August 28, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 41 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |