Duns Number:025460908
Device Description: SURG GL, SENSICARE PI ORTHO LT,LF,PF,7.0
Catalog Number
MSG9970
Brand Name
Medline
Version/Model Number
MSG9970
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
KGO
Product Code Name
Surgeon's gloves
Public Device Record Key
90a7f91d-f0a3-40a2-8786-30bc3e6d6acd
Public Version Date
February 25, 2022
Public Version Number
1
DI Record Publish Date
February 17, 2022
Package DI Number
20193489029854
Quantity per Package
50
Contains DI Package
10193489029857
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |