Duns Number:015272206
Device Description: Fisher spoon and needle, 5 3/8'', double-ended, one needle point end and one 5.0mm x 14.0m Fisher spoon and needle, 5 3/8'', double-ended, one needle point end and one 5.0mm x 14.0mm thin, curved blade, flat handle
Catalog Number
6868E
Brand Name
Ambler Surgical
Version/Model Number
Fisher spoon and needle
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
HNB
Product Code Name
Spoon, ophthalmic
Public Device Record Key
23ec8648-bcc1-488d-9d1f-8de04aa52f4b
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 |