Duns Number:107105876
Device Description: BENGAL STACKABLE CAGE SYSTEM HEIGHT CALIPER 18-66mm Plus or Minus 5.00 Percent
Catalog Number
277306000
Brand Name
BENGAL
Version/Model Number
277306000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KTZ
Product Code Name
CALIPER
Public Device Record Key
9b3b0d20-95c2-4238-b742-a02ab5e388ed
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 31, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5839 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2784 |
| U | Unclassified | 20 |