Duns Number:832696038
Device Description: FERRIS-SMITH-SEWALL ORBITAL RETRACTOR, LARGE SIZE SLOTTED BLADE 6.9X1.3CM WIDE OVERALL LEN FERRIS-SMITH-SEWALL ORBITAL RETRACTOR, LARGE SIZE SLOTTED BLADE 6.9X1.3CM WIDE OVERALL LENGTH 6-1/4"(15.9CM)
Catalog Number
RH4110
Brand Name
V. Mueller
Version/Model Number
RH4110
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
KAL
Product Code Name
RETRACTOR, ENT
Public Device Record Key
9e606411-801e-4817-8d82-f8ed496d8458
Public Version Date
June 07, 2019
Public Version Number
2
DI Record Publish Date
September 10, 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 |