Duns Number:140727624
Device Description: Pediatric Lumbar Puncture Tray with 21ga x 6.3cm Spinal Needle without Lidocaine
Catalog Number
A4304CLF
Brand Name
Pediatric Lumbar Puncture Tray
Version/Model Number
A4304CLF
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
OGJ
Product Code Name
Nerve Block Tray
Public Device Record Key
8f972189-ef6b-4485-ac57-f566e3083530
Public Version Date
May 24, 2018
Public Version Number
1
DI Record Publish Date
April 23, 2018
Package DI Number
20886333224269
Quantity per Package
10
Contains DI Package
00886333224265
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1205 |