Duns Number:125111448
Device Description: Disposable Dilators, Set of 4 Dilators (9-16 mm) 1) 9-10 mm Dilator 1) 11-12 mm Dilator 1 Disposable Dilators, Set of 4 Dilators (9-16 mm) 1) 9-10 mm Dilator 1) 11-12 mm Dilator 1) 13-14 mm Dilator 1) 15-16 mm Dilator
Catalog Number
-
Brand Name
Disposable Dilators
Version/Model Number
720117-01
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
KOA
Product Code Name
Surgical Instruments, G-U, Manual (And Accessories)
Public Device Record Key
7ab58aaf-86fb-4d02-a73d-870c8f7bcfb1
Public Version Date
February 13, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2014
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |
| 3 | A medical device with high risk that requires premarket approval | 139 |