Duns Number:079233827
Device Description: Endoscopic Retrograde Knife
Catalog Number
50118-S
Brand Name
Jigsaw Medical, LLC
Version/Model Number
50118-S
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"
Yes
For Single-Use
Yes
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
NBH
Product Code Name
Accessories, Arthroscopic
Public Device Record Key
88e9a95b-e441-4729-9772-3565769e5d5f
Public Version Date
February 06, 2020
Public Version Number
2
DI Record Publish Date
September 19, 2019
Package DI Number
00856274008262
Quantity per Package
6
Contains DI Package
00856274008101
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 23 |