Duns Number:832696038
Device Description: TESSIER-TYPE RETRACTOR DOUBLE-ENDED, DEEP BLADES 30 X 12MM & 35 X 16MM OVERALL LENGTH 6-1/ TESSIER-TYPE RETRACTOR DOUBLE-ENDED, DEEP BLADES 30 X 12MM & 35 X 16MM OVERALL LENGTH 6-1/4" (15.9CM)
Catalog Number
MO9365
Brand Name
V. Mueller
Version/Model Number
MO9365
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 18, 2019
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
GAD
Product Code Name
RETRACTOR
Public Device Record Key
49a2b28c-0609-41f4-bdc9-35ebafc6cf5b
Public Version Date
March 25, 2020
Public Version Number
2
DI Record Publish Date
September 05, 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 |