Duns Number:832696038
Device Description: COLLIS TAYLOR RETRACTOR REGULAR WIDTH BLADE LENGTH 3-1/2"(8.9CM) OVERALL LENGTH 7-1/4"(18. COLLIS TAYLOR RETRACTOR REGULAR WIDTH BLADE LENGTH 3-1/2"(8.9CM) OVERALL LENGTH 7-1/4"(18.4CM)
Catalog Number
NL9401-005
Brand Name
V. Mueller
Version/Model Number
NL9401-005
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
b0b3255e-dc68-4a3b-9b92-33af7b59e44b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 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 |