Duns Number:004072158
Device Description: Sempermed Syntegra IR Polyisoprene Surgical Glove, size 9
Catalog Number
SIR900
Brand Name
Sempermed Syntegra IR Polyisoprene Surgical Glove
Version/Model Number
SIR900
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGO
Product Code Name
Surgeon'S Gloves
Public Device Record Key
2b1f6ed8-c45b-4d9a-91f0-bf3a7ce38f3b
Public Version Date
April 20, 2022
Public Version Number
3
DI Record Publish Date
January 01, 2020
Package DI Number
10841277102755
Quantity per Package
6
Contains DI Package
00841277102758
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 |