Duns Number:801895244
Device Description: Contents: One syringe of Sperm Select non-pyrogenic sterile membrane filtered, one vial of Contents: One syringe of Sperm Select non-pyrogenic sterile membrane filtered, one vial of Medium non-pyrogenic sterile membrane filtered, one syringe carrier, two 3ml syringe, two 20-G needle, one 21-g needle, one vial holder, one syringe plug and one name tag
Catalog Number
-
Brand Name
Sperm Select System
Version/Model Number
SM600
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
K900308
Product Code
HDR
Product Code Name
Cap, Cervical
Public Device Record Key
391e261b-f2c0-4e85-9456-1aa986508a21
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 09, 2016
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |