Duns Number:355280827
Device Description: NASAL SPECULUM COTTLE STILLE 55 mm with set screw 14 cm 5.5 in
Catalog Number
108-27021-2
Brand Name
STILLE Retractors
Version/Model Number
108-27021-2
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
-
Product Code
EPY
Product Code Name
Speculum, Ent
Public Device Record Key
70b8d668-75cc-4bd1-8b93-0d5a778e0f5e
Public Version Date
October 06, 2020
Public Version Number
1
DI Record Publish Date
September 28, 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 | 1073 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |