Duns Number:537208717
Device Description: The nasal speculum is produced for illumination and therefore examination of the inside of The nasal speculum is produced for illumination and therefore examination of the inside of the nose.
Catalog Number
10803-539
Brand Name
Pack of 1000 pcs. reusable nasal specula Ø 9 mm,
Version/Model Number
10803-539
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K932506
Product Code
EPY
Product Code Name
Speculum, Ent
Public Device Record Key
a178d50a-7261-4a25-be17-f21e8eb80722
Public Version Date
February 05, 2021
Public Version Number
1
DI Record Publish Date
January 28, 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 | 282 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 332 |