Duns Number:809555139
Device Description: Lieberman Child lid speculum, Screw style adjustment for solid precise placement, This des Lieberman Child lid speculum, Screw style adjustment for solid precise placement, This design is intended to lay over the temporal, Unique triple post speculum, 13mm small blades, Stainless Steel
Catalog Number
W20-13
Brand Name
Diamatrix
Version/Model Number
W20-13
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
HNC
Product Code Name
Specula, Ophthalmic
Public Device Record Key
d5282c55-3c2d-4eed-bd04-80d18b48113d
Public Version Date
April 19, 2021
Public Version Number
1
DI Record Publish Date
April 09, 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 | 475 |
| U | Unclassified | 13 |