Duns Number:040729840
Device Description: Helveston Tissue Retractor Flat Handle 9 Millimeters Curved Blades
Catalog Number
-
Brand Name
Helveston Tissue Retractor
Version/Model Number
10-5489
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"
Yes
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
HNI
Product Code Name
Retractor, ophthalmic
Public Device Record Key
fe670a32-aae2-496f-9482-3b727b73f76c
Public Version Date
April 22, 2021
Public Version Number
1
DI Record Publish Date
April 14, 2021
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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |