Duns Number:089055867
Device Description: RING 5189-901 EXPNSN RING USE W 5189-001
Catalog Number
-
Brand Name
Endoscopic Expansion Ring
Version/Model Number
5189-901
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
K003914
Product Code
GWG
Product Code Name
ENDOSCOPE, NEUROLOGICAL
Public Device Record Key
69e7e6c0-777c-42d5-b0f0-1e0a89eeca9a
Public Version Date
March 19, 2021
Public Version Number
4
DI Record Publish Date
June 13, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1465 |