Duns Number:792528510
Device Description: 5mm 45cm Hunter DeBakey, fenestrated 20mm tip, rotatable 1-piece with flush port, type 4 h 5mm 45cm Hunter DeBakey, fenestrated 20mm tip, rotatable 1-piece with flush port, type 4 handle: non-insulated stainless steel with ratchet
Catalog Number
-
Brand Name
Millennium
Version/Model Number
72-5215558B4
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
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
567c31b0-8db6-489a-9c7f-7c01fa143350
Public Version Date
August 19, 2022
Public Version Number
1
DI Record Publish Date
August 11, 2022
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 | 6832 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9482 |