Duns Number:015272206
Device Description: Scleral blade, small European style blade, screw-in, flat stock, packaged individually, st Scleral blade, small European style blade, screw-in, flat stock, packaged individually, sterile, disposable, box of 6
Catalog Number
5700S
Brand Name
Ambler Surgical
Version/Model Number
Scleral blade
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
HNN
Product Code Name
Knife, ophthalmic
Public Device Record Key
e56d6fe9-9147-4e7a-a8bb-efa0ef76d164
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 2021
Package DI Number
00190660200343
Quantity per Package
6
Contains DI Package
10190660200340
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| 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 |