Duns Number:122561087
Device Description: BD Calibrated Disposable Inoculating Loops, Blue 10 microliter
Catalog Number
220216
Brand Name
BD Calibrated Disposable Inoculating Loops, Blue 10 microliter
Version/Model Number
220216
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
LXG
Product Code Name
EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE
Public Device Record Key
d0d8e457-30df-4822-85bb-155f1822c11e
Public Version Date
December 08, 2021
Public Version Number
4
DI Record Publish Date
May 25, 2018
Package DI Number
30382902202166
Quantity per Package
250
Contains DI Package
00382902202165
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfpack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |