Duns Number:876570990
Device Description: Lieberman open wire lid speculum, angled 45°, k-wire adjustable 15mm open blades, thumb-sc Lieberman open wire lid speculum, angled 45°, k-wire adjustable 15mm open blades, thumb-screw tension
Catalog Number
-
Brand Name
Medetz Surgical Instruments
Version/Model Number
12-04560
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
HOD
Product Code Name
Clamp, Eyelid, Ophthalmic
Public Device Record Key
3fdc371d-afae-45c4-8898-b0151218f619
Public Version Date
March 03, 2022
Public Version Number
1
DI Record Publish Date
February 23, 2022
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 | 120 |