Duns Number:015272206
Device Description: Capsule polisher, 23 gauge, 9.0mm angled silicone tip, packaged individually, sterile, dis Capsule polisher, 23 gauge, 9.0mm angled silicone tip, packaged individually, sterile, disposable, box of 3 * * SPECIAL ORDER PRODUCT - MINIMUM ORDER OF 10 BOXES AND 4-6 WEEK LEAD TIME * *
Catalog Number
175121
Brand Name
Ambler Surgical
Version/Model Number
Capsule polisher
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
HMX
Product Code Name
Cannula, ophthalmic
Public Device Record Key
3fef7980-6f75-4416-82ff-a4f669e10115
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 2021
Package DI Number
00190660199210
Quantity per Package
10
Contains DI Package
10190660199217
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 |