Duns Number:021056726
Device Description: I-PACK Injection Kit With Speculum
Catalog Number
18069W
Brand Name
Synergetics
Version/Model Number
18069W
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
-
Product Code
KDD
Product Code Name
Kit, Surgical Instrument, Disposable
Public Device Record Key
8f014fd3-4379-454e-ac43-d2419c54c61d
Public Version Date
June 08, 2020
Public Version Number
1
DI Record Publish Date
May 31, 2020
Package DI Number
20841305107612
Quantity per Package
10
Contains DI Package
10841305101132
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 336 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |