Duns Number:825673239
Device Description: RECEPTAL™ DOUBLE 1/4 INCH (0.64 CM) MALE "T", "O" RING AND SCREW
Catalog Number
443000415
Brand Name
RECEPTAL™ DOUBLE 1/4 INCH (0.64 CM) MALE "T", "O" RING AND SCREW
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
c7e83dad-562b-4ea0-a59f-99210497c8fd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 27, 2017
Package DI Number
40704411000434
Quantity per Package
1
Contains DI Package
10704411000433
Package Discontinue Date
-
Package Status
-
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 |