Duns Number:511268005
Device Description: STEELEX MONOFIL 6 (8) 6X45CM LP
Catalog Number
G0098523
Brand Name
Steelex
Version/Model Number
G0098523
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
-
Product Code
GAQ
Product Code Name
SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
Public Device Record Key
ce406284-f447-4918-80ba-cfc4585dbd17
Public Version Date
October 14, 2021
Public Version Number
7
DI Record Publish Date
August 19, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 13 |