Duns Number:958758146
Device Description: GGTS05B Glide & Guide Turn System Kit Includes: 1 each - GGS5660 and 1 set - BPW11R; 10 Ki GGTS05B Glide & Guide Turn System Kit Includes: 1 each - GGS5660 and 1 set - BPW11R; 10 Kit/Case
Catalog Number
GGTS05B
Brand Name
Glide & Guide Turn System Kit
Version/Model Number
GGTS05B
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
d44785be-ccff-4418-b8fb-4828e359c8d0
Public Version Date
August 03, 2021
Public Version Number
1
DI Record Publish Date
July 26, 2021
Package DI Number
10810006684060
Quantity per Package
10
Contains DI Package
00810006684063
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 208 |