Duns Number:958758146
Device Description: GGTS04 Glide & Guide Turn System Kit Economy Includes: 1 each - GGE3660 and 1 set - BPW11R GGTS04 Glide & Guide Turn System Kit Economy Includes: 1 each - GGE3660 and 1 set - BPW11R; 10 Kit/Case
Catalog Number
GGTS04
Brand Name
Glide & Guide Turn System Kit Economy
Version/Model Number
GGTS04
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
f169ff1e-11fb-4c8b-bd94-b849cec0fb5e
Public Version Date
August 03, 2021
Public Version Number
1
DI Record Publish Date
July 26, 2021
Package DI Number
10810006684091
Quantity per Package
10
Contains DI Package
00810006684094
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 |