Duns Number:124367223
Device Description: Weisman Open Sided Speculum, with Smoke Evacuation Tube, Small, Right Side Open
Catalog Number
SD1552268
Brand Name
Surgical Direct
Version/Model Number
SD1552268
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
HDF
Product Code Name
Speculum, Vaginal, Metal
Public Device Record Key
71b8776a-2966-4ecc-aa48-1a48e1b70dcd
Public Version Date
May 07, 2020
Public Version Number
1
DI Record Publish Date
April 29, 2020
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 | 129 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1010 |