Duns Number:965352946
Device Description: PERL Localization Device, 17Ga x 11.5cm Needle
Catalog Number
-
Brand Name
PERL Localization Device
Version/Model Number
R2020
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 01, 2017
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"
-
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
GDF
Product Code Name
Guide, Needle, Surgical
Public Device Record Key
ae6cb016-c61e-44c7-a162-00e9c72c71dc
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
April 05, 2017
Package DI Number
10851766006099
Quantity per Package
5
Contains DI Package
00851766006092
Package Discontinue Date
August 01, 2017
Package Status
Not in Commercial Distribution
Package Type
Shelf Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |