Duns Number:315018218
Device Description: DOYEN Vaginal Specula, 9 1/2", (240 mm), depth: 160 mm, width: 60 mm, non-sterile, reusabl DOYEN Vaginal Specula, 9 1/2", (240 mm), depth: 160 mm, width: 60 mm, non-sterile, reusable
Catalog Number
EL644R
Brand Name
AESCULAP
Version/Model Number
EL644R
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
HDL
Product Code Name
RETRACTOR, VAGINAL
Public Device Record Key
ef77b4db-b80c-475b-a1df-2848546cf82a
Public Version Date
April 28, 2020
Public Version Number
1
DI Record Publish Date
April 20, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |