Duns Number:020198912
Device Description: Trocar Sleeve w/Stability Sleeve
Catalog Number
CB12LT
Brand Name
N/A
Version/Model Number
N/A
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
NLM
Product Code Name
LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
Public Device Record Key
2cbdec04-001d-4292-8713-026595cdc421
Public Version Date
November 16, 2020
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
30885825014439
Quantity per Package
6
Contains DI Package
00885825014438
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 304 |
2 | A medical device with a moderate to high risk that requires special controls. | 1702 |
U | Unclassified | 12 |