Duns Number:835465063
Device Description: VENT TUBE 9128033 100PK SPIRES GROM PAIR
Catalog Number
-
Brand Name
Spires
Version/Model Number
9128033
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
ETD
Product Code Name
TUBE, TYMPANOSTOMY
Public Device Record Key
efd6313c-1dff-40cb-bdad-5da09902183d
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
July 13, 2015
Package DI Number
20681490195595
Quantity per Package
100
Contains DI Package
00681490195591
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 665 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1575 |
| 3 | A medical device with high risk that requires premarket approval | 6 |
| U | Unclassified | 10 |