Duns Number:514619238
Device Description: The Adult B.I.G. device is indicated to provide intraosseous access into the proximal tibi The Adult B.I.G. device is indicated to provide intraosseous access into the proximal tibia and proximal humeral head in adult patients older than 12 years.
Catalog Number
-
Brand Name
B.I.G.
Version/Model Number
B.I.G.- 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
K062940,K981853,K062940,K981853
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
de6b816c-e2a1-46a7-a86c-99d086f6e4c4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 12, 2017
Package DI Number
17290008325032
Quantity per Package
12
Contains DI Package
07290008325035
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |