Duns Number:001137280
Device Description: 10 mm Cherry-tipped Endoscopic Dissector Stick
Catalog Number
37000010
Brand Name
FABCO
Version/Model Number
37000010
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
Yes
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
GDI
Product Code Name
Dissector, Surgical, General & Plastic Surgery
Public Device Record Key
28dc5f72-1451-4e85-a1b5-10e04d21f25d
Public Version Date
May 07, 2018
Public Version Number
1
DI Record Publish Date
April 06, 2018
Package DI Number
50634303025399
Quantity per Package
10
Contains DI Package
30634303025395
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Dispenser Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 75 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |