Duns Number:015272206
Device Description: Keuch small pupil dilator, 5'', 0.7mm shaft diameter, two point stretching of the pupul wi Keuch small pupil dilator, 5'', 0.7mm shaft diameter, two point stretching of the pupul with 1 extendable finger, round handle
Catalog Number
7194E
Brand Name
Ambler Surgical
Version/Model Number
Keuch small pupil dilator
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
HNW
Product Code Name
Dilator, lachrymal
Public Device Record Key
c81393ed-ec6a-4b46-8ba0-616d1f4b8ab6
Public Version Date
January 15, 2021
Public Version Number
1
DI Record Publish Date
January 07, 2021
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 | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |