Duns Number:025460908
Device Description: DRAPE HAND
Catalog Number
SPT-8610SCS
Brand Name
Medline
Version/Model Number
SPT-8610SCS
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
PUI
Product Code Name
Drape, surgical, exempt
Public Device Record Key
59c78013-ddbc-4f4b-a932-fcdeb4634d37
Public Version Date
February 04, 2021
Public Version Number
1
DI Record Publish Date
January 27, 2021
Package DI Number
40884389030661
Quantity per Package
20
Contains DI Package
10884389030660
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 | 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 |