Duns Number:081277700
Device Description: PESSARY SHAATZ, SIZE 4
Catalog Number
30-SH4
Brand Name
Integra® Miltex®
Version/Model Number
30SH4
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K092981
Product Code
HHW
Product Code Name
PESSARY, VAGINAL
Public Device Record Key
5458b008-91f0-4263-98f2-e43f39374474
Public Version Date
December 06, 2021
Public Version Number
6
DI Record Publish Date
August 26, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 15051 |
2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
3 | A medical device with high risk that requires premarket approval | 2 |
U | Unclassified | 3 |