Duns Number:832696038
Device Description: MCCULLOCH NARROW MUSCLE BLADES 9 X 2 CM WIDE PAIR
Catalog Number
NL9702-127
Brand Name
V. Mueller
Version/Model Number
NL9702-127
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
GZT
Product Code Name
RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY
Public Device Record Key
30bc4a47-4d3b-4616-a5fc-80f3590ea443
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
June 24, 2019
Package DI Number
70885403486083
Quantity per Package
2
Contains DI Package
10885403486081
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pair
| 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 |