Duns Number:809555139
Device Description: Lieberman lid speculum, Screw style adjustment for solid precise placement, This design is Lieberman lid speculum, Screw style adjustment for solid precise placement, This design is intended to lay over the temporal, 14mm Open Square Blades, Titanium
Catalog Number
W25T-14
Brand Name
Diamatrix
Version/Model Number
W25T-14
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
e2ff7a4b-60ca-4f4f-9f00-517d873406c8
Public Version Date
June 29, 2021
Public Version Number
1
DI Record Publish Date
June 21, 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 |