Duns Number:007198742
Device Description: The function of the clip is to hold tissue together until healing is accomplished similar The function of the clip is to hold tissue together until healing is accomplished similar to standard sutures suturing clips and staples used for other procedures
Catalog Number
-
Brand Name
WILLIAMS MICROCLIP 13 MM WIRE DIAMETER STAINLESS
Version/Model Number
145285
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
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
K780586,K780586
Product Code
GDW
Product Code Name
Staple, Implantable
Public Device Record Key
03f6270b-9178-4a01-a48e-2dfb2fe13e76
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 2015
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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |