Duns Number:151179769
Device Description: OB ORGANIC REG NO APLC 24ct 8/3
Catalog Number
-
Brand Name
OB
Version/Model Number
02983
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HEB
Product Code Name
TAMPON, MENSTRUAL, UNSCENTED
Public Device Record Key
f56318d5-3ecc-4222-b382-4a635eef63de
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
July 26, 2019
Package DI Number
10078300029837
Quantity per Package
24
Contains DI Package
00078300029830
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 54 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 65 |