Duns Number:015272206
Device Description: Non-vacuum trephine punch, 8.00mm diameter, for donor cornea, sterile, disposable, box of Non-vacuum trephine punch, 8.00mm diameter, for donor cornea, sterile, disposable, box of 1
Catalog Number
340800
Brand Name
Ambler Surgical
Version/Model Number
Non-vacuum trephine punch
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
Yes
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
HRH
Product Code Name
Trephine, manual, ophthalmic
Public Device Record Key
43f32ca6-9719-4861-9678-eafe1ac2881e
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 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 | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |