Duns Number:832696038
Device Description: GLENNER UTERINE FORCEPS CURVED LEFT FOR PATIENTS RIGHT OVERALL LENGTH 8-1/4"(21CM)
Catalog Number
GL3122-001
Brand Name
V. Mueller
Version/Model Number
GL3122-001
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HGC
Product Code Name
CLAMP, UTERINE
Public Device Record Key
b8e39a4e-47d7-402d-9174-5395049f8def
Public Version Date
August 21, 2019
Public Version Number
3
DI Record Publish Date
August 17, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |