Duns Number:015272206
Device Description: Scleral eye shield, small, 20.0mm x 28.0mm, non-reflective exterior surface, sold as a pai Scleral eye shield, small, 20.0mm x 28.0mm, non-reflective exterior surface, sold as a pair
Catalog Number
9301E
Brand Name
Ambler Surgical
Version/Model Number
Scleral eye shield
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
-
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
HOY
Product Code Name
Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
Public Device Record Key
3a229dcb-dcf7-4018-b2e2-9f17643418c6
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 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 |