Duns Number:015272206
Device Description: Heaney-Ballentine hysterectomy forceps, 10 1/2'', straight, longitudinal serrated, single- Heaney-Ballentine hysterectomy forceps, 10 1/2'', straight, longitudinal serrated, single-toothed jaws, ring handle
Catalog Number
130-970
Brand Name
Ambler Value Line
Version/Model Number
Heaney-Ballentine hysterectomy forceps
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
48e7e75c-5630-4212-a914-bf31165f1d6f
Public Version Date
January 15, 2021
Public Version Number
1
DI Record Publish Date
January 07, 2021
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 | 14984 |
2 | A medical device with a moderate to high risk that requires special controls. | 3118 |