Duns Number:330961223
Device Description: Hospital Device
Catalog Number
-
Brand Name
Trumpf Medical
Version/Model Number
1580889
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KQM
Product Code Name
CAMERA, SURGICAL AND ACCESSORIES
Public Device Record Key
c59f7c4f-007e-4edd-abc0-161c1ba3b912
Public Version Date
October 18, 2018
Public Version Number
1
DI Record Publish Date
September 17, 2018
Package DI Number
10887761995809
Quantity per Package
3
Contains DI Package
00887761995796
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 624 |
2 | A medical device with a moderate to high risk that requires special controls. | 48 |