Duns Number:002397347
Device Description: ESPOCAN® 18 Ga. x 4-1/2 in. Tuohy with backeye lumen and PENCAN® 27 Ga. x 6 in. Pencil-Poi ESPOCAN® 18 Ga. x 4-1/2 in. Tuohy with backeye lumen and PENCAN® 27 Ga. x 6 in. Pencil-Point Spinal Needle
Catalog Number
333152
Brand Name
Espocan®
Version/Model Number
333152
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
OFT
Product Code Name
Spinal epidural anesthesia kit
Public Device Record Key
f6f24e2a-f40c-4193-8a65-d96ce419b2b8
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 |