Duns Number:190572854
Device Description: EXPRESSEW III Autocapture Loading Tool Retention Plate For use with AutoCapture Flexible S EXPRESSEW III Autocapture Loading Tool Retention Plate For use with AutoCapture Flexible Suture Passer
Catalog Number
214158
Brand Name
EXPRESSEW
Version/Model Number
214158
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 28, 2021
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
Yes
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
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
8e9b36e4-0fe6-474c-9343-ba742beb5711
Public Version Date
September 27, 2021
Public Version Number
6
DI Record Publish Date
September 01, 2015
Package DI Number
20886705025203
Quantity per Package
5
Contains DI Package
10886705025206
Package Discontinue Date
January 28, 2021
Package Status
Not in Commercial Distribution
Package Type
Package
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 560 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |