Duns Number:017283879
Device Description: The MiniFESS Maxillary Seeker Set contains reusable, stainless steel surgical instruments The MiniFESS Maxillary Seeker Set contains reusable, stainless steel surgical instruments used to probe within the sinuses using a trans-nasal approach. The seeker set includes a seeker with a 120 degree bend and a seeker with a 135 degree bend.
Catalog Number
-
Brand Name
MiniFess Maxilary Seeker Set
Version/Model Number
MS-255
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
LRC
Product Code Name
Instrument, Ent Manual Surgical
Public Device Record Key
ac37a76e-04bb-478b-ad66-43ae38a83d11
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
September 08, 2020
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |