Duns Number:958758146
Device Description: Glide & Guide Turn Sheet (36" x 60") w/ Top Straps
Catalog Number
GGS3660TSF
Brand Name
Glide & Guide Turn Sheet Select
Version/Model Number
GGS3660TSF
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
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
FMR
Product Code Name
Device, Transfer, Patient, Manual
Public Device Record Key
4ef65f2c-6dcf-4e68-8fd1-8149dd286e50
Public Version Date
September 09, 2020
Public Version Number
2
DI Record Publish Date
February 27, 2019
Package DI Number
00810006680775
Quantity per Package
8
Contains DI Package
00810006680386
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 | 208 |