Duns Number:015272206
Device Description: Pepose micro capsule polishing curette, 6'', double-ended, oblong 0.76mm x 1.0mm polishing Pepose micro capsule polishing curette, 6'', double-ended, oblong 0.76mm x 1.0mm polishing rings, round handle
Catalog Number
5488E
Brand Name
Ambler Surgical
Version/Model Number
Pepose micro capsule polishing curette
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
HNZ
Product Code Name
Curette, ophthalmic
Public Device Record Key
ea3fd7a7-a8f5-4c4d-b773-c3c943e21caa
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 |