Duns Number:839138955
Device Description: DeBakey, 5mm, Atraumatic Serrations with Ratchet Handle: 8510-02 Composite French Style, DeBakey, 5mm, Atraumatic Serrations with Ratchet Handle: 8510-02 Composite French Style, 30cm Length
Catalog Number
-
Brand Name
Speedlock
Version/Model Number
8514-85-30-R/8510-02
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
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
a4ce82f3-b370-4d87-928e-7779608c1fe9
Public Version Date
August 21, 2019
Public Version Number
3
DI Record Publish Date
December 19, 2016
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 | 579 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6418 |