Duns Number:002418234
Device Description: 1111LPT648 Lumbar Puncture Tray w/ 20g x 3.5" Spinal Needle & Manometer
Catalog Number
6487
Brand Name
Busse Hospital Disposables
Version/Model Number
6487
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMJ
Product Code Name
Manometer, Spinal-Fluid
Public Device Record Key
afd7c7c8-e6e7-4313-ab81-5a02efba8005
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 13, 2016
Package DI Number
10849233002507
Quantity per Package
10
Contains DI Package
00849233002500
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 298 |