Duns Number:809555139
Device Description: Lehner Eye Speculum, .035" Stainless wire, This design is intended to lay over the bridge Lehner Eye Speculum, .035" Stainless wire, This design is intended to lay over the bridge of the nose, 14mm Open square blades, 18mm Blade spread, 41mm total length, Stainless
Catalog Number
W80N-14
Brand Name
Diamatrix
Version/Model Number
W80N-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
db560ae2-2964-4df5-bc71-2fd07f2d523a
Public Version Date
May 05, 2021
Public Version Number
1
DI Record Publish Date
April 27, 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 |