Duns Number:488293218
Device Description: Single Use Silc Cup with tubing (Obstetrics)The Single Use Silc Cup is intended to assist Single Use Silc Cup with tubing (Obstetrics)The Single Use Silc Cup is intended to assist a clinician in the vacuum delivery of an infant during childbirth. The device is single use.
Catalog Number
-
Brand Name
Single Use Silc Cup with tubing (Obstetrics)
Version/Model Number
077.0791
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
K130123,K041579,K041579,K130123,K130123,K041579
Product Code
BTA
Product Code Name
Pump, Portable, Aspiration (Manual Or Powered)
Public Device Record Key
e3df1593-519d-4edf-b252-33683949b12d
Public Version Date
May 31, 2022
Public Version Number
4
DI Record Publish Date
May 13, 2019
Package DI Number
07612367037815
Quantity per Package
25
Contains DI Package
07612367009355
Package Discontinue Date
May 31, 2022
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |