Duns Number:140727624
Device Description: T-Lok™ Bone Marrow Tray without Lidocaine
Catalog Number
BMT1104ATLLF
Brand Name
T-Lok™ Bone Marrow Tray
Version/Model Number
BMT1104ATLLF
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"
Yes
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
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
dbe0bc71-c247-4a9a-86b4-4d101ca18677
Public Version Date
May 28, 2018
Public Version Number
1
DI Record Publish Date
April 25, 2018
Package DI Number
20886333224139
Quantity per Package
5
Contains DI Package
00886333224135
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 347 |
2 | A medical device with a moderate to high risk that requires special controls. | 1205 |