Duns Number:257382580
Device Description: The Caliper is a measuring instrument intended to measure the skin or the eyelids' muscles The Caliper is a measuring instrument intended to measure the skin or the eyelids' muscles that the surgeon wants to remove or shorten. The instrument touches directly onto the patient's eyelid and tissue that will be operated. It is partially non-glare: the ruler is not surface treated. It is usually used before the laser. Full scale is 20 mm and resolution is 0.5 mm.
Catalog Number
-
Brand Name
Castroviejo Caliper (non glare), refurb.
Version/Model Number
25-140R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 24, 2022
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTY
Product Code Name
Tape, Measuring, Rulers And Calipers
Public Device Record Key
a06c0292-48bf-4a45-bc46-b683f81b5c49
Public Version Date
March 25, 2022
Public Version Number
2
DI Record Publish Date
November 21, 2019
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 | 192 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |