Duns Number:078352849
Device Description: Seldin retractor used to retract and protect soft tissue, to give better visualization an Seldin retractor used to retract and protect soft tissue, to give better visualization and access a during surgery. This instrument has a handle that is wide, and flatter that the regular round handles.
Catalog Number
Seldin #23 Mini Flat
Brand Name
Seldin Retractor
Version/Model Number
Seldin #23 Mini Flat
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
EIG
Product Code Name
Retractor, All Types
Public Device Record Key
2155ec0b-732b-46c8-9757-d28cab5f9826
Public Version Date
December 30, 2021
Public Version Number
1
DI Record Publish Date
December 22, 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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |