Duns Number:191705904
Device Description: 4"X36", X-Ray, Prewashed, 4 Ply, Vaginal Sponge, Steam Treated, Banded In 5’S White, No Op 4"X36", X-Ray, Prewashed, 4 Ply, Vaginal Sponge, Steam Treated, Banded In 5’S White, No Optical Brightener, 5 Pc(s)/Bundle, 1200 Pc(s)/Case
Catalog Number
LS-0436-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
35421734-31df-49c5-b28b-32da8c891a0e
Public Version Date
October 27, 2022
Public Version Number
1
DI Record Publish Date
October 19, 2022
Package DI Number
80683534840296
Quantity per Package
1200
Contains DI Package
00683534840290
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 |