Duns Number:191705904
Device Description: 8"X4", 16 Ply, Banded 10’S, X-Ray (Single Straight), Stream Pretreated, Type Vii, Bleached 8"X4", 16 Ply, Banded 10’S, X-Ray (Single Straight), Stream Pretreated, Type Vii, Bleached White, 200 Pc(s)/Bag, 2000 Pc(s)/Case
Catalog Number
GZ-8416-6S
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
GDY
Product Code Name
Gauze/Sponge, Internal, X-Ray Detectable
Public Device Record Key
2ee4c38b-36fa-4a1f-8bbd-5b1b4173fdc9
Public Version Date
October 27, 2022
Public Version Number
1
DI Record Publish Date
October 19, 2022
Package DI Number
80683534860249
Quantity per Package
2000
Contains DI Package
00683534860243
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 |