Duns Number:043833813
Device Description: Pig, Pro-Tec, 3/6cc, White
Catalog Number
001-281
Brand Name
PRO-TEC PIG
Version/Model Number
001-281
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IWR
Product Code Name
Holder, Syringe, Lead
Public Device Record Key
d2b6093b-dc44-427f-94d9-85e171958351
Public Version Date
April 22, 2019
Public Version Number
1
DI Record Publish Date
April 12, 2019
Package DI Number
10718175000820
Quantity per Package
6
Contains DI Package
00718175000823
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 | 193 |
2 | A medical device with a moderate to high risk that requires special controls. | 52 |