Duns Number:825673239
Device Description: SPECIMEN TRAP 4 INCH (10 CM) POUR SPOUT COVERWITH 3/8 INCH (0.95 CM) COLLECTION PORT, TETH SPECIMEN TRAP 4 INCH (10 CM) POUR SPOUT COVERWITH 3/8 INCH (0.95 CM) COLLECTION PORT, TETHERED CAP
Catalog Number
433030411
Brand Name
SPECIMEN TRAP 4 INCH (10 CM) POUR SPOUT COVER
Version/Model Number
1
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
0242e3c0-e698-43e1-8d52-10fd994c923c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
40704411004142
Quantity per Package
24
Contains DI Package
10704411004141
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 89 |
2 | A medical device with a moderate to high risk that requires special controls. | 411 |
U | Unclassified | 1 |