Duns Number:004321519
Device Description: 10X15INSLF SEL ATCLV PCH 100PK
Catalog Number
0181257
Brand Name
Fisherbrand
Version/Model Number
SCLF1015
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
b79b23c5-fa3b-4939-8f65-0b2ee2283985
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20613647000001
Quantity per Package
5
Contains DI Package
00613647000007
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 129 |
2 | A medical device with a moderate to high risk that requires special controls. | 36 |