Duns Number:002348191
Device Description: SPONGE PEANUT STERILE XRAY FOAM 3/8" 200/ BOX
Catalog Number
200217
Brand Name
PILLING
Version/Model Number
IPN004251
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
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
K913302,K913302,K913302
Product Code
GDY
Product Code Name
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Public Device Record Key
a98281fb-b904-426e-ad92-6219475b8acd
Public Version Date
October 16, 2018
Public Version Number
1
DI Record Publish Date
September 15, 2018
Package DI Number
24026704417678
Quantity per Package
40
Contains DI Package
04026704417674
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |