Duns Number:002397347
Device Description: PERIFIX® 17 Ga. x 3-1/2 in. Tuohy, PENCAN® 27 Ga. x 5 in. Pencil-Point Spinal Needle, PERI PERIFIX® 17 Ga. x 3-1/2 in. Tuohy, PENCAN® 27 Ga. x 5 in. Pencil-Point Spinal Needle, PERIFIX® FX 19 Ga. Springwound Open Tip, 5 mL Glass Luer Slip LOR Tray (Kit)
Catalog Number
333197
Brand Name
Combined Spinal & Epidural
Version/Model Number
333197
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OFT
Product Code Name
Spinal epidural anesthesia kit
Public Device Record Key
f78fa7b0-400a-4c2d-b8ea-d88675bed0ab
Public Version Date
February 17, 2021
Public Version Number
6
DI Record Publish Date
September 23, 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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 277 |
| U | Unclassified | 2 |