Duns Number:832696038
Device Description: MCLANE-TUCKER OBSTETRICAL FORCEPS, 1 PAIR SOLID BLADES, LONG OVERALL LENGTH 16-1/4"(41.3CM MCLANE-TUCKER OBSTETRICAL FORCEPS, 1 PAIR SOLID BLADES, LONG OVERALL LENGTH 16-1/4"(41.3CM)
Catalog Number
GL5530-4
Brand Name
V. Mueller
Version/Model Number
GL5530-4
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
HDA
Product Code Name
Forceps, obstetrical
Public Device Record Key
f4e7d82d-6a3b-4d66-ad11-3153be0f9118
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
September 21, 2016
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 |