Duns Number:191705904
Device Description: Bulk Lap Sponges , 12"X12", X-Ray Detectable, Prewashed, Steam Pretreatment, White, No Opt Bulk Lap Sponges , 12"X12", X-Ray Detectable, Prewashed, Steam Pretreatment, White, No Optical Brightener , 5 Pc(s)/Bundle, 1400 Pc(s)/Case
Catalog Number
LS-1212-PS
Brand Name
A Plus
Version/Model Number
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAB
Product Code Name
Gauze / Sponge,Nonresorbable For External Use
Public Device Record Key
8f9f0453-c6ca-4480-bd96-f3201a34a5d5
Public Version Date
October 27, 2022
Public Version Number
1
DI Record Publish Date
October 19, 2022
Package DI Number
80683534840104
Quantity per Package
1400
Contains DI Package
00683534840108
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 | 83 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 29 |