Duns Number:597723837
Device Description: Standard quiver, PVC loop, polypropylene, individually packaged and sterile.Device Intende Standard quiver, PVC loop, polypropylene, individually packaged and sterile.Device Intended Use: Holder for electrosurgical diathermy system conducting unit and/or other long instruments during surgery. For single use only.
Catalog Number
A100398
Brand Name
ITL Essential Standard Quiver
Version/Model Number
A100398
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
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
K153472,K153472
Product Code
HAM
Product Code Name
Apparatus, Electrosurgical
Public Device Record Key
23b3b5c6-6bff-4e08-8788-d9e11e691353
Public Version Date
June 03, 2019
Public Version Number
1
DI Record Publish Date
May 25, 2019
Package DI Number
19555240400748
Quantity per Package
30
Contains DI Package
19555240401141
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |