Duns Number:809555139
Device Description: Varley Lasik K-wire lid speculum, .039" Heavy stainless wire, Temporal, 14mm Open square b Varley Lasik K-wire lid speculum, .039" Heavy stainless wire, Temporal, 14mm Open square blades with modified bent shafts, 30mm Blade spread, 60mm total length, Stainless
Catalog Number
W48
Brand Name
Diamatrix
Version/Model Number
W48
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
6a7cd5cd-10b0-417b-858f-e793a97dc378
Public Version Date
March 17, 2021
Public Version Number
1
DI Record Publish Date
March 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 |