Duns Number:058614483
Device Description: Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing Processing or Repac Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing Processing or Repacking.
Catalog Number
-
Brand Name
Situate
Version/Model Number
L1836-04P01CN-1
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
GDY
Product Code Name
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Public Device Record Key
0a753133-be36-43d0-96e8-7325a430c3ca
Public Version Date
August 12, 2022
Public Version Number
4
DI Record Publish Date
August 19, 2018
Package DI Number
20884521706948
Quantity per Package
2
Contains DI Package
10884521706941
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |