Duns Number:958758146
Device Description: Economy Glide & Guide Turn Sheet (36" x 60")
Catalog Number
GGE3660
Brand Name
Economy Glide & Guide Turn Sheet
Version/Model Number
GGE3660
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"
-
For Single-Use
-
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
FMR
Product Code Name
Device, Transfer, Patient, Manual
Public Device Record Key
ea85aaf4-fb74-46bf-9934-e31b73a1aa8a
Public Version Date
July 08, 2021
Public Version Number
1
DI Record Publish Date
June 30, 2021
Package DI Number
10810006684039
Quantity per Package
50
Contains DI Package
00810006684032
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 | 208 |